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American Diabetes Association (ADA): Annual Scientific Sessions
Insulin independence achieved with novel stem cell therapy
SAN FRANCISCO – Autologous nonmyeloablative hematopoietic stem cell transplantation achieved insulin independence* in 59% of subjects with new-onset type 1 diabetes at 6 months of follow-up, and in 32% of subjects at up to 48 months of follow-up, results from a multicenter trial showed.
"Exogenous insulin therapy does not always achieve metabolic control in type 1 diabetes, nor prevent the occurrence of complications or halt beta-cell decline," Dr. Francesca D’Addio said at the annual scientific sessions of the American Diabetes Association. "Several clinical trials based on the preclinical successful targeting of innate/adaptive immune responses failed in type 1 diabetes. Recent trials conducted worldwide succeeded in exploiting hematopoietic stem cells [HSCs] to treat new-onset type 1 diabetes."
Dr. D’Addio of the Boston Children’s Hospital transplant research center noted that the rationale to use HSCs in type 1 diabetes is based on their immunoregulatory properties, "to rescue peripheral tolerance toward pancreatic beta cells." She presented updated results on the worldwide use of autologous HSC transplantation (AHSCT) in patients with type 1 diabetes, in an effort to evaluate potential adverse events "and to explore the successes and potential pitfalls of this novel therapy." Participating centers included the Medical University of Warsaw, the Affiliated Drum Tower Hospital of Nanjing (China), and Shanghai (China) Jiao Tong University.
The researchers screened 65 individuals aged 12-35 years who were diagnosed with type 1 diabetes within the past year and who were positive for at least one autoantibody against beta-cell antigens. Other inclusion criteria included the absence of cardiomyopathy, severe diabetic complications, malignancy, acute and chronic infection, liver disease, kidney diseases, allergic disease, and pregnancy.
At baseline, the mean age of study participants was 20 years, 63% were male, and their mean body mass index was 18 kg/m2. Autologous HSCs were administered after mobilization with hemopoietic growth factor granulocyte colony-stimulating factor (G-CSF) plus cyclophosphamide with an induction therapy based on cyclophosphamide and antithymocyte globulin (200 mg/kg and 4.5 mg/kg for 4 and 5 days, respectively).
Dr. D’Addio reported that insulin independence was achieved in 100% of individuals at least once during a follow-up period of up to 48 months, and mainly within the first 6 months after treatment. At the 6-month time point, 59% of patients had achieved insulin independence*, compared with 32% of subjects who were followed up to 48 months.
The researchers also observed a significant decrease in hemoglobin A1c level at 6 months, from a pretreatment level of 87.2 mmol/mol (10.1%) to 42.2 mmol/mol (6.0%) and then maintained over time, as well as a significant increase in C-peptide levels that was maintained up to 48 months (from a pretreatment level of 0.5 ng/mL to 1.2 ng/mL).
Slightly more than half of patients (52%) experienced adverse events, primarily neutropenic fever (seven cases), alopecia/gastric tract symptoms (five cases), and alopecia/fever (three cases). Treatment responders, defined as those who were insulin dependent at least 6 months after transplantation, showed improved glycometabolic status and beta-cell function, compared with nonresponders. They also had a greater number of CD34-positive cells injected.
"The response to AHSCT depends on the number of CD34-positive cells injected and relies on their immunoregulatory properties," Dr. D’Addio concluded. "HSC-based safer therapeutic options are required, including engineering of HSCs."
Dr. D’Addio said she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
Correction, 6/16/2014: An earlier version of this article misstated the impact of the study intervention on insulin independence.
SAN FRANCISCO – Autologous nonmyeloablative hematopoietic stem cell transplantation achieved insulin independence* in 59% of subjects with new-onset type 1 diabetes at 6 months of follow-up, and in 32% of subjects at up to 48 months of follow-up, results from a multicenter trial showed.
"Exogenous insulin therapy does not always achieve metabolic control in type 1 diabetes, nor prevent the occurrence of complications or halt beta-cell decline," Dr. Francesca D’Addio said at the annual scientific sessions of the American Diabetes Association. "Several clinical trials based on the preclinical successful targeting of innate/adaptive immune responses failed in type 1 diabetes. Recent trials conducted worldwide succeeded in exploiting hematopoietic stem cells [HSCs] to treat new-onset type 1 diabetes."
Dr. D’Addio of the Boston Children’s Hospital transplant research center noted that the rationale to use HSCs in type 1 diabetes is based on their immunoregulatory properties, "to rescue peripheral tolerance toward pancreatic beta cells." She presented updated results on the worldwide use of autologous HSC transplantation (AHSCT) in patients with type 1 diabetes, in an effort to evaluate potential adverse events "and to explore the successes and potential pitfalls of this novel therapy." Participating centers included the Medical University of Warsaw, the Affiliated Drum Tower Hospital of Nanjing (China), and Shanghai (China) Jiao Tong University.
The researchers screened 65 individuals aged 12-35 years who were diagnosed with type 1 diabetes within the past year and who were positive for at least one autoantibody against beta-cell antigens. Other inclusion criteria included the absence of cardiomyopathy, severe diabetic complications, malignancy, acute and chronic infection, liver disease, kidney diseases, allergic disease, and pregnancy.
At baseline, the mean age of study participants was 20 years, 63% were male, and their mean body mass index was 18 kg/m2. Autologous HSCs were administered after mobilization with hemopoietic growth factor granulocyte colony-stimulating factor (G-CSF) plus cyclophosphamide with an induction therapy based on cyclophosphamide and antithymocyte globulin (200 mg/kg and 4.5 mg/kg for 4 and 5 days, respectively).
Dr. D’Addio reported that insulin independence was achieved in 100% of individuals at least once during a follow-up period of up to 48 months, and mainly within the first 6 months after treatment. At the 6-month time point, 59% of patients had achieved insulin independence*, compared with 32% of subjects who were followed up to 48 months.
The researchers also observed a significant decrease in hemoglobin A1c level at 6 months, from a pretreatment level of 87.2 mmol/mol (10.1%) to 42.2 mmol/mol (6.0%) and then maintained over time, as well as a significant increase in C-peptide levels that was maintained up to 48 months (from a pretreatment level of 0.5 ng/mL to 1.2 ng/mL).
Slightly more than half of patients (52%) experienced adverse events, primarily neutropenic fever (seven cases), alopecia/gastric tract symptoms (five cases), and alopecia/fever (three cases). Treatment responders, defined as those who were insulin dependent at least 6 months after transplantation, showed improved glycometabolic status and beta-cell function, compared with nonresponders. They also had a greater number of CD34-positive cells injected.
"The response to AHSCT depends on the number of CD34-positive cells injected and relies on their immunoregulatory properties," Dr. D’Addio concluded. "HSC-based safer therapeutic options are required, including engineering of HSCs."
Dr. D’Addio said she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
Correction, 6/16/2014: An earlier version of this article misstated the impact of the study intervention on insulin independence.
SAN FRANCISCO – Autologous nonmyeloablative hematopoietic stem cell transplantation achieved insulin independence* in 59% of subjects with new-onset type 1 diabetes at 6 months of follow-up, and in 32% of subjects at up to 48 months of follow-up, results from a multicenter trial showed.
"Exogenous insulin therapy does not always achieve metabolic control in type 1 diabetes, nor prevent the occurrence of complications or halt beta-cell decline," Dr. Francesca D’Addio said at the annual scientific sessions of the American Diabetes Association. "Several clinical trials based on the preclinical successful targeting of innate/adaptive immune responses failed in type 1 diabetes. Recent trials conducted worldwide succeeded in exploiting hematopoietic stem cells [HSCs] to treat new-onset type 1 diabetes."
Dr. D’Addio of the Boston Children’s Hospital transplant research center noted that the rationale to use HSCs in type 1 diabetes is based on their immunoregulatory properties, "to rescue peripheral tolerance toward pancreatic beta cells." She presented updated results on the worldwide use of autologous HSC transplantation (AHSCT) in patients with type 1 diabetes, in an effort to evaluate potential adverse events "and to explore the successes and potential pitfalls of this novel therapy." Participating centers included the Medical University of Warsaw, the Affiliated Drum Tower Hospital of Nanjing (China), and Shanghai (China) Jiao Tong University.
The researchers screened 65 individuals aged 12-35 years who were diagnosed with type 1 diabetes within the past year and who were positive for at least one autoantibody against beta-cell antigens. Other inclusion criteria included the absence of cardiomyopathy, severe diabetic complications, malignancy, acute and chronic infection, liver disease, kidney diseases, allergic disease, and pregnancy.
At baseline, the mean age of study participants was 20 years, 63% were male, and their mean body mass index was 18 kg/m2. Autologous HSCs were administered after mobilization with hemopoietic growth factor granulocyte colony-stimulating factor (G-CSF) plus cyclophosphamide with an induction therapy based on cyclophosphamide and antithymocyte globulin (200 mg/kg and 4.5 mg/kg for 4 and 5 days, respectively).
Dr. D’Addio reported that insulin independence was achieved in 100% of individuals at least once during a follow-up period of up to 48 months, and mainly within the first 6 months after treatment. At the 6-month time point, 59% of patients had achieved insulin independence*, compared with 32% of subjects who were followed up to 48 months.
The researchers also observed a significant decrease in hemoglobin A1c level at 6 months, from a pretreatment level of 87.2 mmol/mol (10.1%) to 42.2 mmol/mol (6.0%) and then maintained over time, as well as a significant increase in C-peptide levels that was maintained up to 48 months (from a pretreatment level of 0.5 ng/mL to 1.2 ng/mL).
Slightly more than half of patients (52%) experienced adverse events, primarily neutropenic fever (seven cases), alopecia/gastric tract symptoms (five cases), and alopecia/fever (three cases). Treatment responders, defined as those who were insulin dependent at least 6 months after transplantation, showed improved glycometabolic status and beta-cell function, compared with nonresponders. They also had a greater number of CD34-positive cells injected.
"The response to AHSCT depends on the number of CD34-positive cells injected and relies on their immunoregulatory properties," Dr. D’Addio concluded. "HSC-based safer therapeutic options are required, including engineering of HSCs."
Dr. D’Addio said she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
Correction, 6/16/2014: An earlier version of this article misstated the impact of the study intervention on insulin independence.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Autologous hematopoietic stem cell transplantation was effective in patients with recently diagnosed type 1 diabetes, but that effect waned over time.
Major finding: At the 6-month time point after AHSCT, 59% of patients had achieved insulin dependence, compared with 32% of subjects who were followed up to 48 months.
Data source: A study of 65 individuals with a mean age of 20 years who were diagnosed with type 1 diabetes within the past year and who underwent autologous nonmyeloablative hematopoietic stem cell transplantation at one of three clinical sites.
Disclosures: Dr. D’Addio said she had no relevant financial conflicts to disclose.
U.S. diabetes epidemic may be slowing
SAN FRANCISCO – The U.S. incidence of adult diabetes doubled between 1980 and 2008 but has fallen a bit since then, which may be a sign that the diabetes epidemic is abating, according to Linda S. Geiss a health statistician with the Centers for Disease Control and Prevention.
This potentially good news does not apply to everyone, however. Both the incidence and prevalence of diabetes continue to increase in Hispanics, non-Hispanic blacks, and adults with less than a high school education, Ms. Geiss and her associates reported at the annual scientific session of the American Diabetes Association.
They studied annual data from the 1980-2012 National Health Interview Surveys to identify diabetes trends in U.S. residents aged 20-79 years. The age-adjusted prevalence and incidence of diagnosed diabetes changed little in the 1980s but each doubled between 1990 and 2008, she said.
During that time period, the U.S. population became older, less white, and better educated, she noted.
The age-adjusted incidence of diabetes increased from approximately 4/1,000 people in 1980 to more than 9/1,000 in 2008 and then declined to less than 8/1,000 in 2012, a statistically insignificant decrease after 2008. The age-adjusted prevalence of diabetes increased from approximately 4/100 people in 1980 to approximately 8/100 in 2008, with a slight increase after that, "although at a slower rate of pace," Ms. Geiss said.
Even when incidence declines, prevalence can continue to rise if the number of deaths among people with diabetes is smaller than the number of new diagnoses.
"Overall and for some subpopulations, incidence and/or prevalence slowed or plateaued around 2008. Some groups slowed earlier in the 2000s," she said. "After a steady 15- to 20-year increase in prevalence and incidence, we are seeing the first signs that the growth may be slowing or abating. However, given the uncertainty about the reasons behind these changes, future trends are uncertain. Given the large burden of diabetes in the United States, we need to sustain efforts to prevent diabetes and its complications," especially among population groups whose incidence and prevalence rates continue to climb.
Throughout the time period studied, the incidence and prevalence of diabetes were lowest among people aged 20-44 years and highest among people aged 65-79 years. For those two age groups, the incidence of diabetes increased throughout the time period. For middle-aged people of 45-64 years, the incidence plateaued in 2002. The prevalence of diabetes plateaued in 2008 for the middle-aged group and in 2003 for the oldest age group.
Incidence rates for men started to exceed those for women around 1997, continued increasing until 2008, and then declined, though not significantly. The incidence for women increased throughout the time period studied. The prevalence of diabetes plateaued for men in 2001 and for women in 2008.
For adults with a high school education, the incidence of diabetes increased until 2008 and then decreased insignificantly. For other educational levels (more than or less than a high school education), the incidence increased throughout the period. The prevalence slowed among people with more than a high school education in 2000, but increased throughout the time period for the other educational levels.
The incidence and prevalence of diabetes were higher among Hispanics and non-Hispanic blacks than among whites between 1997 and 2012. For whites, the incidence increased from approximately 5/1,000 people in 1997 to 8/1,000 in 2008, then decreased insignificantly to 6/1,000 in 2012. The prevalence of diabetes in whites slowed its rate of increase starting in 2005, Ms. Geiss reported.
"With these cross-sectional data, you can’t determine the reasons behind trend changes," she said. The nationally representative data spanning 3 decades give strength to the findings, but the surveys did not include institutionalized residents or people with undiagnosed diabetes. The study could not distinguish trends for type 1 vs. type 2 diabetes.
One physician in the audience asked if the global financial crisis in 2008 may have been a factor in slowing the diabetes epidemic.
Ms. Geiss said she hadn’t considered that possible explanation. Other factors that may have affected the incidence of diabetes include the adoption of hemoglobin A1c (HbA1c) for the diagnosis of diabetes, she speculated. "We know that HbA1c tends to identify fewer people who have hyperglycemia," she said. Also, U.S. obesity rates have not increased since 2003-2004, and a couple of separate studies have reported declining caloric intake by the U.S. population. Each of these factors may be "prominent drivers" of the slowing incidence of diabetes, she said.
Ms. Geiss reported having no financial disclosures.
On Twitter @sherryboschert
This was an interesting study. One thing to consider is whether the CDC has changed the way it defines diabetes, which the speaker hinted that they sort of have. She hinted that the HbA1c is less sensitive to diabetes. So, if you changed the way you diagnose diabetes, and you get a different number of people diagnosed with diabetes, it may be that there are truly fewer cases of diabetes or it may just be that the new test didn’t pick up all of the people the old tests did.
I think the public health messages shouldn’t change: Be active. Don’t gain weight. And all the other diabetes prevention messages. If primary care doctors have been encouraging people to do that, maybe this is evidence that their work is paying off. That would be a positive message.
Dr. Amanda Adler is consultant physician at Cambridge (England) University’s Addenbrooke’s Hospital and chair of the technology appraisals committee for the National Institute for Health and Clinical Excellence, England. She gave these comments in an interview at the meeting.
This was an interesting study. One thing to consider is whether the CDC has changed the way it defines diabetes, which the speaker hinted that they sort of have. She hinted that the HbA1c is less sensitive to diabetes. So, if you changed the way you diagnose diabetes, and you get a different number of people diagnosed with diabetes, it may be that there are truly fewer cases of diabetes or it may just be that the new test didn’t pick up all of the people the old tests did.
I think the public health messages shouldn’t change: Be active. Don’t gain weight. And all the other diabetes prevention messages. If primary care doctors have been encouraging people to do that, maybe this is evidence that their work is paying off. That would be a positive message.
Dr. Amanda Adler is consultant physician at Cambridge (England) University’s Addenbrooke’s Hospital and chair of the technology appraisals committee for the National Institute for Health and Clinical Excellence, England. She gave these comments in an interview at the meeting.
This was an interesting study. One thing to consider is whether the CDC has changed the way it defines diabetes, which the speaker hinted that they sort of have. She hinted that the HbA1c is less sensitive to diabetes. So, if you changed the way you diagnose diabetes, and you get a different number of people diagnosed with diabetes, it may be that there are truly fewer cases of diabetes or it may just be that the new test didn’t pick up all of the people the old tests did.
I think the public health messages shouldn’t change: Be active. Don’t gain weight. And all the other diabetes prevention messages. If primary care doctors have been encouraging people to do that, maybe this is evidence that their work is paying off. That would be a positive message.
Dr. Amanda Adler is consultant physician at Cambridge (England) University’s Addenbrooke’s Hospital and chair of the technology appraisals committee for the National Institute for Health and Clinical Excellence, England. She gave these comments in an interview at the meeting.
SAN FRANCISCO – The U.S. incidence of adult diabetes doubled between 1980 and 2008 but has fallen a bit since then, which may be a sign that the diabetes epidemic is abating, according to Linda S. Geiss a health statistician with the Centers for Disease Control and Prevention.
This potentially good news does not apply to everyone, however. Both the incidence and prevalence of diabetes continue to increase in Hispanics, non-Hispanic blacks, and adults with less than a high school education, Ms. Geiss and her associates reported at the annual scientific session of the American Diabetes Association.
They studied annual data from the 1980-2012 National Health Interview Surveys to identify diabetes trends in U.S. residents aged 20-79 years. The age-adjusted prevalence and incidence of diagnosed diabetes changed little in the 1980s but each doubled between 1990 and 2008, she said.
During that time period, the U.S. population became older, less white, and better educated, she noted.
The age-adjusted incidence of diabetes increased from approximately 4/1,000 people in 1980 to more than 9/1,000 in 2008 and then declined to less than 8/1,000 in 2012, a statistically insignificant decrease after 2008. The age-adjusted prevalence of diabetes increased from approximately 4/100 people in 1980 to approximately 8/100 in 2008, with a slight increase after that, "although at a slower rate of pace," Ms. Geiss said.
Even when incidence declines, prevalence can continue to rise if the number of deaths among people with diabetes is smaller than the number of new diagnoses.
"Overall and for some subpopulations, incidence and/or prevalence slowed or plateaued around 2008. Some groups slowed earlier in the 2000s," she said. "After a steady 15- to 20-year increase in prevalence and incidence, we are seeing the first signs that the growth may be slowing or abating. However, given the uncertainty about the reasons behind these changes, future trends are uncertain. Given the large burden of diabetes in the United States, we need to sustain efforts to prevent diabetes and its complications," especially among population groups whose incidence and prevalence rates continue to climb.
Throughout the time period studied, the incidence and prevalence of diabetes were lowest among people aged 20-44 years and highest among people aged 65-79 years. For those two age groups, the incidence of diabetes increased throughout the time period. For middle-aged people of 45-64 years, the incidence plateaued in 2002. The prevalence of diabetes plateaued in 2008 for the middle-aged group and in 2003 for the oldest age group.
Incidence rates for men started to exceed those for women around 1997, continued increasing until 2008, and then declined, though not significantly. The incidence for women increased throughout the time period studied. The prevalence of diabetes plateaued for men in 2001 and for women in 2008.
For adults with a high school education, the incidence of diabetes increased until 2008 and then decreased insignificantly. For other educational levels (more than or less than a high school education), the incidence increased throughout the period. The prevalence slowed among people with more than a high school education in 2000, but increased throughout the time period for the other educational levels.
The incidence and prevalence of diabetes were higher among Hispanics and non-Hispanic blacks than among whites between 1997 and 2012. For whites, the incidence increased from approximately 5/1,000 people in 1997 to 8/1,000 in 2008, then decreased insignificantly to 6/1,000 in 2012. The prevalence of diabetes in whites slowed its rate of increase starting in 2005, Ms. Geiss reported.
"With these cross-sectional data, you can’t determine the reasons behind trend changes," she said. The nationally representative data spanning 3 decades give strength to the findings, but the surveys did not include institutionalized residents or people with undiagnosed diabetes. The study could not distinguish trends for type 1 vs. type 2 diabetes.
One physician in the audience asked if the global financial crisis in 2008 may have been a factor in slowing the diabetes epidemic.
Ms. Geiss said she hadn’t considered that possible explanation. Other factors that may have affected the incidence of diabetes include the adoption of hemoglobin A1c (HbA1c) for the diagnosis of diabetes, she speculated. "We know that HbA1c tends to identify fewer people who have hyperglycemia," she said. Also, U.S. obesity rates have not increased since 2003-2004, and a couple of separate studies have reported declining caloric intake by the U.S. population. Each of these factors may be "prominent drivers" of the slowing incidence of diabetes, she said.
Ms. Geiss reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – The U.S. incidence of adult diabetes doubled between 1980 and 2008 but has fallen a bit since then, which may be a sign that the diabetes epidemic is abating, according to Linda S. Geiss a health statistician with the Centers for Disease Control and Prevention.
This potentially good news does not apply to everyone, however. Both the incidence and prevalence of diabetes continue to increase in Hispanics, non-Hispanic blacks, and adults with less than a high school education, Ms. Geiss and her associates reported at the annual scientific session of the American Diabetes Association.
They studied annual data from the 1980-2012 National Health Interview Surveys to identify diabetes trends in U.S. residents aged 20-79 years. The age-adjusted prevalence and incidence of diagnosed diabetes changed little in the 1980s but each doubled between 1990 and 2008, she said.
During that time period, the U.S. population became older, less white, and better educated, she noted.
The age-adjusted incidence of diabetes increased from approximately 4/1,000 people in 1980 to more than 9/1,000 in 2008 and then declined to less than 8/1,000 in 2012, a statistically insignificant decrease after 2008. The age-adjusted prevalence of diabetes increased from approximately 4/100 people in 1980 to approximately 8/100 in 2008, with a slight increase after that, "although at a slower rate of pace," Ms. Geiss said.
Even when incidence declines, prevalence can continue to rise if the number of deaths among people with diabetes is smaller than the number of new diagnoses.
"Overall and for some subpopulations, incidence and/or prevalence slowed or plateaued around 2008. Some groups slowed earlier in the 2000s," she said. "After a steady 15- to 20-year increase in prevalence and incidence, we are seeing the first signs that the growth may be slowing or abating. However, given the uncertainty about the reasons behind these changes, future trends are uncertain. Given the large burden of diabetes in the United States, we need to sustain efforts to prevent diabetes and its complications," especially among population groups whose incidence and prevalence rates continue to climb.
Throughout the time period studied, the incidence and prevalence of diabetes were lowest among people aged 20-44 years and highest among people aged 65-79 years. For those two age groups, the incidence of diabetes increased throughout the time period. For middle-aged people of 45-64 years, the incidence plateaued in 2002. The prevalence of diabetes plateaued in 2008 for the middle-aged group and in 2003 for the oldest age group.
Incidence rates for men started to exceed those for women around 1997, continued increasing until 2008, and then declined, though not significantly. The incidence for women increased throughout the time period studied. The prevalence of diabetes plateaued for men in 2001 and for women in 2008.
For adults with a high school education, the incidence of diabetes increased until 2008 and then decreased insignificantly. For other educational levels (more than or less than a high school education), the incidence increased throughout the period. The prevalence slowed among people with more than a high school education in 2000, but increased throughout the time period for the other educational levels.
The incidence and prevalence of diabetes were higher among Hispanics and non-Hispanic blacks than among whites between 1997 and 2012. For whites, the incidence increased from approximately 5/1,000 people in 1997 to 8/1,000 in 2008, then decreased insignificantly to 6/1,000 in 2012. The prevalence of diabetes in whites slowed its rate of increase starting in 2005, Ms. Geiss reported.
"With these cross-sectional data, you can’t determine the reasons behind trend changes," she said. The nationally representative data spanning 3 decades give strength to the findings, but the surveys did not include institutionalized residents or people with undiagnosed diabetes. The study could not distinguish trends for type 1 vs. type 2 diabetes.
One physician in the audience asked if the global financial crisis in 2008 may have been a factor in slowing the diabetes epidemic.
Ms. Geiss said she hadn’t considered that possible explanation. Other factors that may have affected the incidence of diabetes include the adoption of hemoglobin A1c (HbA1c) for the diagnosis of diabetes, she speculated. "We know that HbA1c tends to identify fewer people who have hyperglycemia," she said. Also, U.S. obesity rates have not increased since 2003-2004, and a couple of separate studies have reported declining caloric intake by the U.S. population. Each of these factors may be "prominent drivers" of the slowing incidence of diabetes, she said.
Ms. Geiss reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ADA ANNUAL SCIENTIFIC SESSION
Key clinical point: Your diabetes prevention efforts may be working. Keep at it!
Major finding: The incidence of diabetes increased from approximately 4/1,000 U.S. adults in 1980 to 9/1,000 in 2008, then declined insignificantly to less than 8/1,000 in 2012.
Data source: An analysis of annual data on people aged 20-79 years from the 1980-2012 National Health Interview Surveys.
Disclosures: Ms. Geiss reported having no financial disclosures.
Cancer risk elevated before and 90 days after diabetes diagnosis
SAN FRANCISCO – Among diabetes patients, the risk of cancer was significantly increased before diagnosis and 3 months after diabetes diagnosis, but not beyond that time point, results from a population-based study showed.
"Previous studies have focused on the risk of cancer following diabetes diagnosis or else compared risk of cancer between the pre- and postdiabetes period without taking into account the time period immediately following the diagnosis of diabetes," lead investigator Dr. Iliana C. Lega said in an interview prior to the annual scientific sessions of the American Diabetes Association, where the research was presented.
"We found that risk of cancer was highest in the prediabetes period and in the first 3 months following diabetes diagnosis, suggesting a role for hyperinsulinemia in the pathogenesis of cancer in the diabetes population. Furthermore, increased detection of preexisting cancers in the period following diabetes diagnosis may also contribute to the observed elevated risk of cancer," she said.
Dr. Lega, a clinician scientist with the division of endocrinology and metabolism at the University of Toronto, and her associates used population-based data from Ontario during 1997-2009 to identify incident diabetic cohorts that were matched 1:1 by age and gender to patients without diabetes. The researchers used time-varying Cox regression models to compare the relative risk of any invasive cancer between patients with and without diabetes in three separate time frames: 10 years prior to diagnosis, 3 months after diagnosis, and more than 3 months after diabetes diagnosis.
Dr. Lega and her associates evaluated cancer risk before diabetes diagnosis in 186,441 diabetes patients and matched controls and after diabetes in 51,463 diabetes patients and matched controls. Among diabetes patients, the risk of cancer was significantly increased before diabetes diagnosis (hazard ratio, 1.23) and 3 months after diabetes diagnosis (HR, 1.69), but the association abated beyond 3 months after diabetes diagnosis.
The findings "support a role for hyperinsulinemia in the relationship between diabetes and cancer, over surveillance bias," the researchers concluded in their abstract. "While further research is needed, these results support enhanced cancer screening in patients with diagnoses of prediabetes or diabetes."
Dr. Lega acknowledged certain limitations of the study, including the fact that other risk factors for cancer such as clinical features, smoking history, chronic alcoholism, and family history could not be taken into account.
Dr. Lega said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among diabetes patients, the risk of cancer was significantly increased before diagnosis and 3 months after diabetes diagnosis, but not beyond that time point, results from a population-based study showed.
"Previous studies have focused on the risk of cancer following diabetes diagnosis or else compared risk of cancer between the pre- and postdiabetes period without taking into account the time period immediately following the diagnosis of diabetes," lead investigator Dr. Iliana C. Lega said in an interview prior to the annual scientific sessions of the American Diabetes Association, where the research was presented.
"We found that risk of cancer was highest in the prediabetes period and in the first 3 months following diabetes diagnosis, suggesting a role for hyperinsulinemia in the pathogenesis of cancer in the diabetes population. Furthermore, increased detection of preexisting cancers in the period following diabetes diagnosis may also contribute to the observed elevated risk of cancer," she said.
Dr. Lega, a clinician scientist with the division of endocrinology and metabolism at the University of Toronto, and her associates used population-based data from Ontario during 1997-2009 to identify incident diabetic cohorts that were matched 1:1 by age and gender to patients without diabetes. The researchers used time-varying Cox regression models to compare the relative risk of any invasive cancer between patients with and without diabetes in three separate time frames: 10 years prior to diagnosis, 3 months after diagnosis, and more than 3 months after diabetes diagnosis.
Dr. Lega and her associates evaluated cancer risk before diabetes diagnosis in 186,441 diabetes patients and matched controls and after diabetes in 51,463 diabetes patients and matched controls. Among diabetes patients, the risk of cancer was significantly increased before diabetes diagnosis (hazard ratio, 1.23) and 3 months after diabetes diagnosis (HR, 1.69), but the association abated beyond 3 months after diabetes diagnosis.
The findings "support a role for hyperinsulinemia in the relationship between diabetes and cancer, over surveillance bias," the researchers concluded in their abstract. "While further research is needed, these results support enhanced cancer screening in patients with diagnoses of prediabetes or diabetes."
Dr. Lega acknowledged certain limitations of the study, including the fact that other risk factors for cancer such as clinical features, smoking history, chronic alcoholism, and family history could not be taken into account.
Dr. Lega said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among diabetes patients, the risk of cancer was significantly increased before diagnosis and 3 months after diabetes diagnosis, but not beyond that time point, results from a population-based study showed.
"Previous studies have focused on the risk of cancer following diabetes diagnosis or else compared risk of cancer between the pre- and postdiabetes period without taking into account the time period immediately following the diagnosis of diabetes," lead investigator Dr. Iliana C. Lega said in an interview prior to the annual scientific sessions of the American Diabetes Association, where the research was presented.
"We found that risk of cancer was highest in the prediabetes period and in the first 3 months following diabetes diagnosis, suggesting a role for hyperinsulinemia in the pathogenesis of cancer in the diabetes population. Furthermore, increased detection of preexisting cancers in the period following diabetes diagnosis may also contribute to the observed elevated risk of cancer," she said.
Dr. Lega, a clinician scientist with the division of endocrinology and metabolism at the University of Toronto, and her associates used population-based data from Ontario during 1997-2009 to identify incident diabetic cohorts that were matched 1:1 by age and gender to patients without diabetes. The researchers used time-varying Cox regression models to compare the relative risk of any invasive cancer between patients with and without diabetes in three separate time frames: 10 years prior to diagnosis, 3 months after diagnosis, and more than 3 months after diabetes diagnosis.
Dr. Lega and her associates evaluated cancer risk before diabetes diagnosis in 186,441 diabetes patients and matched controls and after diabetes in 51,463 diabetes patients and matched controls. Among diabetes patients, the risk of cancer was significantly increased before diabetes diagnosis (hazard ratio, 1.23) and 3 months after diabetes diagnosis (HR, 1.69), but the association abated beyond 3 months after diabetes diagnosis.
The findings "support a role for hyperinsulinemia in the relationship between diabetes and cancer, over surveillance bias," the researchers concluded in their abstract. "While further research is needed, these results support enhanced cancer screening in patients with diagnoses of prediabetes or diabetes."
Dr. Lega acknowledged certain limitations of the study, including the fact that other risk factors for cancer such as clinical features, smoking history, chronic alcoholism, and family history could not be taken into account.
Dr. Lega said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Among people with type 2 diabetes, cancer risk is elevated before and 3 months after diagnosis.
Major finding: The risk of cancer was significantly increased before diabetes diagnosis (HR, 1.23) and 3 months after diabetes diagnosis (HR, 1.69; P less than .001), but not beyond that time point (HR, 1.04).
Data source: A population-based study of patients from Ontario during 1997-2009.
Disclosures: Dr. Lega said that she had no relevant financial conflicts.
Fatty heart may bring on diabetes
SAN FRANCISCO – A high volume of pericardial adipose tissue was associated with the prevalence of diabetes, independent of overall obesity, results from a long-term, diverse cohort study showed.
"Obesity is associated with an increased risk for cardiovascular disease and type 2 diabetes, and specific fat deposits may increase the risk more than others," Amy C. Alman, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The findings come from an analysis of year-25 exam data among 3,079 participants in CARDIA (Coronary Artery Risk Development in Young Adults), a longitudinal cohort study of the development of cardiovascular risk and disease that began in 1985 and was conducted at centers in Alabama, Minnesota, Illinois, and California.
Visceral adiposity "is metabolically active and more strongly associated with cardiovascular risk than subcutaneous adiposity. Ectopic adipose depots are metabolically active fat found in and around tissues and organs throughout the body, including the liver, muscles, and around the heart," explained Dr. Alman of the department of epidemiology and biostatistics at the University of South Florida, Tampa.
Pericardial adipose tissue (PAT) is an ectopic fat depot composed of epicardial adipose tissue deep to the pericardium and surrounding the coronary arteries and paracardial tissue, which is located along the surface of the parietal pericardium. She and her associates tested whether PAT was positively associated with prevalent diabetes at the year-25 exam of the CARDIA study.
Examinations including volume of PAT measures from chest CT scans were performed during 2010-2011, and the researchers used multivariable logistic regression to examine the relation between quartiles of PAT and diabetes. There were four PAT quartiles: less than 33.5 cm3 (quartile 1/referent volume), between 33.5 and less than 48.7 cm3 (quartile 2), between 48.7 and less than 71.7 cm3 (quartile 3), and greater than 71.7 cm3 (quartile 4).
The mean age of the 3,079 study participants was 51 years, 44% were male, and their average body mass index was 31 kg/m2. Of these, 419 had prevalent diabetes. The prevalence of diabetes was highest in the fourth quartile of PAT volume (46% vs. 12% in the first quartile, 18% in the second, and 24% in the third), Dr. Alman reported.
In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (odds ratio, 2.47), adjusted for field center, gender, age, race, systolic blood pressure, total cholesterol, triglycerides, and treatment with blood pressure– and cholesterol-lowering medications. A similar association was observed among nonobese patients (OR, 3.78).
"Deposition of a higher proportion of metabolically active ectopic fat is associated with diabetes in both obese and nonobese individuals," Dr. Alman concluded.
The analysis was "a very well characterized multicenter cohort study with a diverse racial cohort of middle-aged men and women," she added. Limitations of the study, she said, included its cross-sectional design, the fact that PAT was measured at a single point in time, and that it did not account for other ectopic fat depots such as liver fat. A longitudinal analysis of the participants is planned.
Dr. Alman had no relevant financial conflicts to disclose.
SAN FRANCISCO – A high volume of pericardial adipose tissue was associated with the prevalence of diabetes, independent of overall obesity, results from a long-term, diverse cohort study showed.
"Obesity is associated with an increased risk for cardiovascular disease and type 2 diabetes, and specific fat deposits may increase the risk more than others," Amy C. Alman, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The findings come from an analysis of year-25 exam data among 3,079 participants in CARDIA (Coronary Artery Risk Development in Young Adults), a longitudinal cohort study of the development of cardiovascular risk and disease that began in 1985 and was conducted at centers in Alabama, Minnesota, Illinois, and California.
Visceral adiposity "is metabolically active and more strongly associated with cardiovascular risk than subcutaneous adiposity. Ectopic adipose depots are metabolically active fat found in and around tissues and organs throughout the body, including the liver, muscles, and around the heart," explained Dr. Alman of the department of epidemiology and biostatistics at the University of South Florida, Tampa.
Pericardial adipose tissue (PAT) is an ectopic fat depot composed of epicardial adipose tissue deep to the pericardium and surrounding the coronary arteries and paracardial tissue, which is located along the surface of the parietal pericardium. She and her associates tested whether PAT was positively associated with prevalent diabetes at the year-25 exam of the CARDIA study.
Examinations including volume of PAT measures from chest CT scans were performed during 2010-2011, and the researchers used multivariable logistic regression to examine the relation between quartiles of PAT and diabetes. There were four PAT quartiles: less than 33.5 cm3 (quartile 1/referent volume), between 33.5 and less than 48.7 cm3 (quartile 2), between 48.7 and less than 71.7 cm3 (quartile 3), and greater than 71.7 cm3 (quartile 4).
The mean age of the 3,079 study participants was 51 years, 44% were male, and their average body mass index was 31 kg/m2. Of these, 419 had prevalent diabetes. The prevalence of diabetes was highest in the fourth quartile of PAT volume (46% vs. 12% in the first quartile, 18% in the second, and 24% in the third), Dr. Alman reported.
In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (odds ratio, 2.47), adjusted for field center, gender, age, race, systolic blood pressure, total cholesterol, triglycerides, and treatment with blood pressure– and cholesterol-lowering medications. A similar association was observed among nonobese patients (OR, 3.78).
"Deposition of a higher proportion of metabolically active ectopic fat is associated with diabetes in both obese and nonobese individuals," Dr. Alman concluded.
The analysis was "a very well characterized multicenter cohort study with a diverse racial cohort of middle-aged men and women," she added. Limitations of the study, she said, included its cross-sectional design, the fact that PAT was measured at a single point in time, and that it did not account for other ectopic fat depots such as liver fat. A longitudinal analysis of the participants is planned.
Dr. Alman had no relevant financial conflicts to disclose.
SAN FRANCISCO – A high volume of pericardial adipose tissue was associated with the prevalence of diabetes, independent of overall obesity, results from a long-term, diverse cohort study showed.
"Obesity is associated with an increased risk for cardiovascular disease and type 2 diabetes, and specific fat deposits may increase the risk more than others," Amy C. Alman, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The findings come from an analysis of year-25 exam data among 3,079 participants in CARDIA (Coronary Artery Risk Development in Young Adults), a longitudinal cohort study of the development of cardiovascular risk and disease that began in 1985 and was conducted at centers in Alabama, Minnesota, Illinois, and California.
Visceral adiposity "is metabolically active and more strongly associated with cardiovascular risk than subcutaneous adiposity. Ectopic adipose depots are metabolically active fat found in and around tissues and organs throughout the body, including the liver, muscles, and around the heart," explained Dr. Alman of the department of epidemiology and biostatistics at the University of South Florida, Tampa.
Pericardial adipose tissue (PAT) is an ectopic fat depot composed of epicardial adipose tissue deep to the pericardium and surrounding the coronary arteries and paracardial tissue, which is located along the surface of the parietal pericardium. She and her associates tested whether PAT was positively associated with prevalent diabetes at the year-25 exam of the CARDIA study.
Examinations including volume of PAT measures from chest CT scans were performed during 2010-2011, and the researchers used multivariable logistic regression to examine the relation between quartiles of PAT and diabetes. There were four PAT quartiles: less than 33.5 cm3 (quartile 1/referent volume), between 33.5 and less than 48.7 cm3 (quartile 2), between 48.7 and less than 71.7 cm3 (quartile 3), and greater than 71.7 cm3 (quartile 4).
The mean age of the 3,079 study participants was 51 years, 44% were male, and their average body mass index was 31 kg/m2. Of these, 419 had prevalent diabetes. The prevalence of diabetes was highest in the fourth quartile of PAT volume (46% vs. 12% in the first quartile, 18% in the second, and 24% in the third), Dr. Alman reported.
In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (odds ratio, 2.47), adjusted for field center, gender, age, race, systolic blood pressure, total cholesterol, triglycerides, and treatment with blood pressure– and cholesterol-lowering medications. A similar association was observed among nonobese patients (OR, 3.78).
"Deposition of a higher proportion of metabolically active ectopic fat is associated with diabetes in both obese and nonobese individuals," Dr. Alman concluded.
The analysis was "a very well characterized multicenter cohort study with a diverse racial cohort of middle-aged men and women," she added. Limitations of the study, she said, included its cross-sectional design, the fact that PAT was measured at a single point in time, and that it did not account for other ectopic fat depots such as liver fat. A longitudinal analysis of the participants is planned.
Dr. Alman had no relevant financial conflicts to disclose.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: The greater the volume of pericardial adipose tissue, the greater the risk of diabetes.
Major finding: In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (OR, 2.47).
Data source: An analysis of data from 3,079 participants at the year-25 exam of the CARDIA study.
Disclosures: Dr. Alman said that she had no relevant financial conflicts.
Weight loss greater with higher-dose liraglutide in diabetes
SAN FRANCISCO – A once-daily subcutaneous injection of an experimental 3-mg dose of liraglutide was significantly more effective than the approved 1.8-mg dose or placebo for weight loss in a randomized, double-blind study of 846 overweight or obese adults with diabetes.
All treatment arms also employed caloric reduction and exercise for weight management. After 56 weeks of therapy, body weight decreased by 5.9% in the 3-mg group, 4.6% in the 1.8-mg group, and 2% in patients on placebo. The mean changes in both liraglutide groups were significantly better than on placebo, and the greater loss on 3 mg, compared with 1.8 mg of liraglutide, also was statistically significant, Dr. Melanie Davies and her associates reported at the annual scientific sessions of the American Diabetes Association.
The percentages of patients who lost at least 5% of body weight by 56 weeks were 50% in the 3-mg group, 36% in the 1.8-mg group, and 14% on placebo. Again, liraglutide at either dose was significantly more effective than placebo, and the higher dose of liraglutide worked significantly better than the lower dose, reported Dr. Davies, professor of diabetes medicine at the University of Leicester (England).
The percentages of patients who lost at least 10% of body weight were 23% in the 3-mg group, 14% in the 1.8-mg group, and 4% on placebo. The same statistical trends were seen, with the higher dose being significantly more effective.
Among secondary outcomes in the SCALE-Diabetes trial (Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes), greater reductions were seen in hemoglobin A1c levels after 56 weeks on the higher drug dose. HbA1c levels fell by 1.3% on the 3-mg dose, compared with 1.1% on the 1.8-mg dose or 0.3% on placebo, Dr. Davies said.
The proportions of patients achieving an HbA1c level of 6.5% or lower were 57% in the 3-mg group, 46% in the 1.8-mg group, and 15% on placebo. The proportions of patients achieving an HbA1c level below 7% were 69% in the 3-mg group, 67% in the 1.8-mg group, and 27% in the placebo group. Fasting glucose levels decreased by 34 mg/dL in the 3-mg group, 25 mg/dL in the 1.8-mg group, and 2 mg/dL on placebo. In each case, the 3-mg dose was more effective than the lower dose or placebo, except that the likelihood of getting HbA1c below 7% was not significantly different between the 3-mg and 1.8-mg liraglutide groups.
Systolic blood pressure measurements decreased by a mean of 3.5 mmHg in the 3-mg group, 2.8 mmHg in the 1.8-mg group, and 0.4 mmHg in the placebo group.
Thirty-four percent in the 3-mg group withdrew before the end of the study, as did 22% in the 1.8-mg group and 23% on placebo.
Rates of side effects were not significantly different between the two liraglutide groups, except for gastrointestinal events, Dr. Davies said. Adverse events were seen in 93% on 3 mg liraglutide, 90% on the 1.8-mg dose, and 86% on placebo. Serious adverse events occurred in 9% in either liraglutide group and in 6% on placebo, and side effects led to withdrawal from the study in 9% of either drug group and in 3% on placebo. Severe episodes of adverse events occurred in 12% in the 3-mg group, 14% in the 1.8-mg group, and 10% on placebo. One death in the 1.8-mg group that occurred after the study ended was not considered to be related to treatment, she said.
The most common side effects were nausea (in 33% on 3 mg, 31% on 1.8 mg, and 14% on placebo), diarrhea (26%, 18%, and 13%, respectively), constipation (16%, 10%, and 6%, respectively), and vomiting (16%, 10%, and 6%, respectively). Most of the increase in nausea among those on the drug resolved by 24 weeks.
Hypoglycemia occurred in 44% of the 3-mg group, 40% of the 1.8-mg group, and 28% in the placebo group and was more common in patients on liraglutide and in patients who also were taking sulfonylurea drugs, she said.
A separate SCALE study in 3,731 nondiabetic patients (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects with Comorbidities) found that the 3-mg dose was more effective for weight loss than placebo in adults without diabetes. Although that study detected rates of pancreatitis and gallbladder disorders that were more than twice as common (though still rare) with liraglutide, compared with placebo, there were no episodes of pancreatitis in the current trial, Dr. Davies said. There was no difference in levels of amylase, which is a marker of pancreatitis, between the two drug arms.
Increased lipase levels were seen in 12% on the 3-mg dose, 10% on the 1.8-mg dose, and 7% on placebo, she said. The drug groups showed roughly a 10-unit increase in lipase that occurred early and was maintained during the duration of the study.
"Obviously, there are still some concerns around pancreatitis with GLP1 drugs as a class, but certainly in this study there were no cases of pancreatitis," Dr. Davies said. Only eight patients developed gallstones in the current study, too few to compare rates between groups, she added.
Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed in those doses as Victoza.
Dr. Davies reported having financial associations with Novo Nordisk, which manufactures liraglutide, and with eight other pharmaceutical companies.
On Twitter @sherryboschert
The take-home message is that this study shows liraglutide 3 mg is effective in terms of weight loss in obese and overweight adults with type 2 diabetes. There also was a beneficial effect on HbA1c. It appeared that the higher dose of 3 mg had even better effects than the currently approved 1.8-mg dose on weight and on HbA1c in this particular patient group. The side effect profile appeared to be similar to the 1.8-mg dose. The 3-mg dose seemed to be safe.
If the 3-mg dose was indicated and licensed, I think it would be entirely reasonable to use it, particularly in the morbidly obese population with type 2 diabetes, because you get a better effect in terms of HbA1c reduction and weight loss.
 |
|
Whenever you’re increasing a dose with any medication, there’s always a concern about promotion of side effects. In this study, it appeared that the higher dose was tolerated really well. There didn’t seem to be a big difference between the 3-mg and 1.8-mg dose in that regard. That’s kind of reassuring for physicians when considering a higher dose.
There are other treatment options, including the SGLT2 (sodium glucose co-transporter 2) inhibitors, which are orally administered and also can promote weight loss by a completely different mechanism. SGLT2 inhibitors are indicated for patients with type 2 diabetes who have poor control. A plus is that they can be orally administered.
If you look at diabetes therapies in general, things like sulfonylureas, thiazolidinediones, and insulin promote weight gain. That’s a big problem because that makes insulin resistance worse. Having a diabetes therapy that can also promote weight loss is hugely beneficial. As a diabetologist, I put huge value on a drug that promotes weight loss in this context. I think we now have two major groups – the GLP1 (glucagon-like peptide 1) agents, of which liraglutide is one, and the SGLT2 inhibitors – both of which can achieve that. I think it’s a very useful addition to our armamentarium and management.
Thomas Barber, M.D., is associate professor and honorary consultant endocrinologist at the University of Warwick, England. He gave these comments in an interview at the meeting. Dr. Barber reported having no financial disclosures.
The take-home message is that this study shows liraglutide 3 mg is effective in terms of weight loss in obese and overweight adults with type 2 diabetes. There also was a beneficial effect on HbA1c. It appeared that the higher dose of 3 mg had even better effects than the currently approved 1.8-mg dose on weight and on HbA1c in this particular patient group. The side effect profile appeared to be similar to the 1.8-mg dose. The 3-mg dose seemed to be safe.
If the 3-mg dose was indicated and licensed, I think it would be entirely reasonable to use it, particularly in the morbidly obese population with type 2 diabetes, because you get a better effect in terms of HbA1c reduction and weight loss.
|
|
Whenever you’re increasing a dose with any medication, there’s always a concern about promotion of side effects. In this study, it appeared that the higher dose was tolerated really well. There didn’t seem to be a big difference between the 3-mg and 1.8-mg dose in that regard. That’s kind of reassuring for physicians when considering a higher dose.
There are other treatment options, including the SGLT2 (sodium glucose co-transporter 2) inhibitors, which are orally administered and also can promote weight loss by a completely different mechanism. SGLT2 inhibitors are indicated for patients with type 2 diabetes who have poor control. A plus is that they can be orally administered.
If you look at diabetes therapies in general, things like sulfonylureas, thiazolidinediones, and insulin promote weight gain. That’s a big problem because that makes insulin resistance worse. Having a diabetes therapy that can also promote weight loss is hugely beneficial. As a diabetologist, I put huge value on a drug that promotes weight loss in this context. I think we now have two major groups – the GLP1 (glucagon-like peptide 1) agents, of which liraglutide is one, and the SGLT2 inhibitors – both of which can achieve that. I think it’s a very useful addition to our armamentarium and management.
Thomas Barber, M.D., is associate professor and honorary consultant endocrinologist at the University of Warwick, England. He gave these comments in an interview at the meeting. Dr. Barber reported having no financial disclosures.
The take-home message is that this study shows liraglutide 3 mg is effective in terms of weight loss in obese and overweight adults with type 2 diabetes. There also was a beneficial effect on HbA1c. It appeared that the higher dose of 3 mg had even better effects than the currently approved 1.8-mg dose on weight and on HbA1c in this particular patient group. The side effect profile appeared to be similar to the 1.8-mg dose. The 3-mg dose seemed to be safe.
If the 3-mg dose was indicated and licensed, I think it would be entirely reasonable to use it, particularly in the morbidly obese population with type 2 diabetes, because you get a better effect in terms of HbA1c reduction and weight loss.
|
|
Whenever you’re increasing a dose with any medication, there’s always a concern about promotion of side effects. In this study, it appeared that the higher dose was tolerated really well. There didn’t seem to be a big difference between the 3-mg and 1.8-mg dose in that regard. That’s kind of reassuring for physicians when considering a higher dose.
There are other treatment options, including the SGLT2 (sodium glucose co-transporter 2) inhibitors, which are orally administered and also can promote weight loss by a completely different mechanism. SGLT2 inhibitors are indicated for patients with type 2 diabetes who have poor control. A plus is that they can be orally administered.
If you look at diabetes therapies in general, things like sulfonylureas, thiazolidinediones, and insulin promote weight gain. That’s a big problem because that makes insulin resistance worse. Having a diabetes therapy that can also promote weight loss is hugely beneficial. As a diabetologist, I put huge value on a drug that promotes weight loss in this context. I think we now have two major groups – the GLP1 (glucagon-like peptide 1) agents, of which liraglutide is one, and the SGLT2 inhibitors – both of which can achieve that. I think it’s a very useful addition to our armamentarium and management.
Thomas Barber, M.D., is associate professor and honorary consultant endocrinologist at the University of Warwick, England. He gave these comments in an interview at the meeting. Dr. Barber reported having no financial disclosures.
SAN FRANCISCO – A once-daily subcutaneous injection of an experimental 3-mg dose of liraglutide was significantly more effective than the approved 1.8-mg dose or placebo for weight loss in a randomized, double-blind study of 846 overweight or obese adults with diabetes.
All treatment arms also employed caloric reduction and exercise for weight management. After 56 weeks of therapy, body weight decreased by 5.9% in the 3-mg group, 4.6% in the 1.8-mg group, and 2% in patients on placebo. The mean changes in both liraglutide groups were significantly better than on placebo, and the greater loss on 3 mg, compared with 1.8 mg of liraglutide, also was statistically significant, Dr. Melanie Davies and her associates reported at the annual scientific sessions of the American Diabetes Association.
The percentages of patients who lost at least 5% of body weight by 56 weeks were 50% in the 3-mg group, 36% in the 1.8-mg group, and 14% on placebo. Again, liraglutide at either dose was significantly more effective than placebo, and the higher dose of liraglutide worked significantly better than the lower dose, reported Dr. Davies, professor of diabetes medicine at the University of Leicester (England).
The percentages of patients who lost at least 10% of body weight were 23% in the 3-mg group, 14% in the 1.8-mg group, and 4% on placebo. The same statistical trends were seen, with the higher dose being significantly more effective.
Among secondary outcomes in the SCALE-Diabetes trial (Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes), greater reductions were seen in hemoglobin A1c levels after 56 weeks on the higher drug dose. HbA1c levels fell by 1.3% on the 3-mg dose, compared with 1.1% on the 1.8-mg dose or 0.3% on placebo, Dr. Davies said.
The proportions of patients achieving an HbA1c level of 6.5% or lower were 57% in the 3-mg group, 46% in the 1.8-mg group, and 15% on placebo. The proportions of patients achieving an HbA1c level below 7% were 69% in the 3-mg group, 67% in the 1.8-mg group, and 27% in the placebo group. Fasting glucose levels decreased by 34 mg/dL in the 3-mg group, 25 mg/dL in the 1.8-mg group, and 2 mg/dL on placebo. In each case, the 3-mg dose was more effective than the lower dose or placebo, except that the likelihood of getting HbA1c below 7% was not significantly different between the 3-mg and 1.8-mg liraglutide groups.
Systolic blood pressure measurements decreased by a mean of 3.5 mmHg in the 3-mg group, 2.8 mmHg in the 1.8-mg group, and 0.4 mmHg in the placebo group.
Thirty-four percent in the 3-mg group withdrew before the end of the study, as did 22% in the 1.8-mg group and 23% on placebo.
Rates of side effects were not significantly different between the two liraglutide groups, except for gastrointestinal events, Dr. Davies said. Adverse events were seen in 93% on 3 mg liraglutide, 90% on the 1.8-mg dose, and 86% on placebo. Serious adverse events occurred in 9% in either liraglutide group and in 6% on placebo, and side effects led to withdrawal from the study in 9% of either drug group and in 3% on placebo. Severe episodes of adverse events occurred in 12% in the 3-mg group, 14% in the 1.8-mg group, and 10% on placebo. One death in the 1.8-mg group that occurred after the study ended was not considered to be related to treatment, she said.
The most common side effects were nausea (in 33% on 3 mg, 31% on 1.8 mg, and 14% on placebo), diarrhea (26%, 18%, and 13%, respectively), constipation (16%, 10%, and 6%, respectively), and vomiting (16%, 10%, and 6%, respectively). Most of the increase in nausea among those on the drug resolved by 24 weeks.
Hypoglycemia occurred in 44% of the 3-mg group, 40% of the 1.8-mg group, and 28% in the placebo group and was more common in patients on liraglutide and in patients who also were taking sulfonylurea drugs, she said.
A separate SCALE study in 3,731 nondiabetic patients (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects with Comorbidities) found that the 3-mg dose was more effective for weight loss than placebo in adults without diabetes. Although that study detected rates of pancreatitis and gallbladder disorders that were more than twice as common (though still rare) with liraglutide, compared with placebo, there were no episodes of pancreatitis in the current trial, Dr. Davies said. There was no difference in levels of amylase, which is a marker of pancreatitis, between the two drug arms.
Increased lipase levels were seen in 12% on the 3-mg dose, 10% on the 1.8-mg dose, and 7% on placebo, she said. The drug groups showed roughly a 10-unit increase in lipase that occurred early and was maintained during the duration of the study.
"Obviously, there are still some concerns around pancreatitis with GLP1 drugs as a class, but certainly in this study there were no cases of pancreatitis," Dr. Davies said. Only eight patients developed gallstones in the current study, too few to compare rates between groups, she added.
Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed in those doses as Victoza.
Dr. Davies reported having financial associations with Novo Nordisk, which manufactures liraglutide, and with eight other pharmaceutical companies.
On Twitter @sherryboschert
SAN FRANCISCO – A once-daily subcutaneous injection of an experimental 3-mg dose of liraglutide was significantly more effective than the approved 1.8-mg dose or placebo for weight loss in a randomized, double-blind study of 846 overweight or obese adults with diabetes.
All treatment arms also employed caloric reduction and exercise for weight management. After 56 weeks of therapy, body weight decreased by 5.9% in the 3-mg group, 4.6% in the 1.8-mg group, and 2% in patients on placebo. The mean changes in both liraglutide groups were significantly better than on placebo, and the greater loss on 3 mg, compared with 1.8 mg of liraglutide, also was statistically significant, Dr. Melanie Davies and her associates reported at the annual scientific sessions of the American Diabetes Association.
The percentages of patients who lost at least 5% of body weight by 56 weeks were 50% in the 3-mg group, 36% in the 1.8-mg group, and 14% on placebo. Again, liraglutide at either dose was significantly more effective than placebo, and the higher dose of liraglutide worked significantly better than the lower dose, reported Dr. Davies, professor of diabetes medicine at the University of Leicester (England).
The percentages of patients who lost at least 10% of body weight were 23% in the 3-mg group, 14% in the 1.8-mg group, and 4% on placebo. The same statistical trends were seen, with the higher dose being significantly more effective.
Among secondary outcomes in the SCALE-Diabetes trial (Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes), greater reductions were seen in hemoglobin A1c levels after 56 weeks on the higher drug dose. HbA1c levels fell by 1.3% on the 3-mg dose, compared with 1.1% on the 1.8-mg dose or 0.3% on placebo, Dr. Davies said.
The proportions of patients achieving an HbA1c level of 6.5% or lower were 57% in the 3-mg group, 46% in the 1.8-mg group, and 15% on placebo. The proportions of patients achieving an HbA1c level below 7% were 69% in the 3-mg group, 67% in the 1.8-mg group, and 27% in the placebo group. Fasting glucose levels decreased by 34 mg/dL in the 3-mg group, 25 mg/dL in the 1.8-mg group, and 2 mg/dL on placebo. In each case, the 3-mg dose was more effective than the lower dose or placebo, except that the likelihood of getting HbA1c below 7% was not significantly different between the 3-mg and 1.8-mg liraglutide groups.
Systolic blood pressure measurements decreased by a mean of 3.5 mmHg in the 3-mg group, 2.8 mmHg in the 1.8-mg group, and 0.4 mmHg in the placebo group.
Thirty-four percent in the 3-mg group withdrew before the end of the study, as did 22% in the 1.8-mg group and 23% on placebo.
Rates of side effects were not significantly different between the two liraglutide groups, except for gastrointestinal events, Dr. Davies said. Adverse events were seen in 93% on 3 mg liraglutide, 90% on the 1.8-mg dose, and 86% on placebo. Serious adverse events occurred in 9% in either liraglutide group and in 6% on placebo, and side effects led to withdrawal from the study in 9% of either drug group and in 3% on placebo. Severe episodes of adverse events occurred in 12% in the 3-mg group, 14% in the 1.8-mg group, and 10% on placebo. One death in the 1.8-mg group that occurred after the study ended was not considered to be related to treatment, she said.
The most common side effects were nausea (in 33% on 3 mg, 31% on 1.8 mg, and 14% on placebo), diarrhea (26%, 18%, and 13%, respectively), constipation (16%, 10%, and 6%, respectively), and vomiting (16%, 10%, and 6%, respectively). Most of the increase in nausea among those on the drug resolved by 24 weeks.
Hypoglycemia occurred in 44% of the 3-mg group, 40% of the 1.8-mg group, and 28% in the placebo group and was more common in patients on liraglutide and in patients who also were taking sulfonylurea drugs, she said.
A separate SCALE study in 3,731 nondiabetic patients (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects with Comorbidities) found that the 3-mg dose was more effective for weight loss than placebo in adults without diabetes. Although that study detected rates of pancreatitis and gallbladder disorders that were more than twice as common (though still rare) with liraglutide, compared with placebo, there were no episodes of pancreatitis in the current trial, Dr. Davies said. There was no difference in levels of amylase, which is a marker of pancreatitis, between the two drug arms.
Increased lipase levels were seen in 12% on the 3-mg dose, 10% on the 1.8-mg dose, and 7% on placebo, she said. The drug groups showed roughly a 10-unit increase in lipase that occurred early and was maintained during the duration of the study.
"Obviously, there are still some concerns around pancreatitis with GLP1 drugs as a class, but certainly in this study there were no cases of pancreatitis," Dr. Davies said. Only eight patients developed gallstones in the current study, too few to compare rates between groups, she added.
Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed in those doses as Victoza.
Dr. Davies reported having financial associations with Novo Nordisk, which manufactures liraglutide, and with eight other pharmaceutical companies.
On Twitter @sherryboschert
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: An investigational 3-mg/day dose of liraglutide may be more effective than 1.8 mg for weight loss in diabetes.
Major finding: Patients on 3 mg/day of liraglutide lost 5.9% of body weight, compared with losses of 4.6% on 1.8 mg/day or 2% on placebo, after 56 weeks of therapy.
Data source: A prospective, randomized, double-blind, placebo-controlled trial of 3 mg or 1.8 mg liraglutide or placebo as adjuncts to diet and exercise in 846 overweight or obese adults with type 2 diabetes.
Disclosures: Dr. Davies reported having financial associations with Novo Nordisk, which manufactures liraglutide, and with eight other pharmaceutical companies.
Bionic pancreas beat standard insulin pump in type 1 diabetes
A bionic insulin-glucagon pancreas achieved significantly better glycemic control than insulin pump therapy in adults and adolescents with type 1 diabetes, researchers reported at the annual scientific sessions of the American Diabetes Association.
The testing conditions in the two 5-day random-order crossover studies "simulated real-world outpatient settings with close monitoring for safety in adults and adolescents. Meals and physical activity were not regulated, in contrast with previous studies," wrote Dr. Stephen Russell at Massachusetts General Hospital and Harvard Medical School in Boston and his associates in a report published simultaneously with the presentation (N. Engl. J. Med. 2014 June 15 [doi: 10.1056/NEJMoa1314474]).
Adults achieved significantly lower mean plasma glucose levels during the bionic-pancreas period compared with the control period (7.4 vs. 8.8 mg/dL), as did adolescents (7.7 vs. 8.7 mg/dL), the investigators said. And differences were significant even though about 75% of patients had better baseline glycemic control than national averages, they said.
The studies included 20 adults from the Beacon Hill Study and 32 adolescents from the Summer Camp Study, said investigators. The bionic pancreas device included an Apple iPhone 4S, whose control algorithm received continuous glucose monitoring data and triggered dosing every 5 minutes, and a G4 Platinum continuous glucose monitor from Dexcom connected to the iPhone by a hardware interface. The device’s user interface showed continuous glucose readings and insulin and glucagon doses, and enabled the wearer to record meal sizes as typical, more than usual, less than usual, or a "small bite." Based on meal size, the device adapted the insulin dose to meet 75% of the estimated 4-hour postprandial need. If the glucose sensor failed, the device automatically delivered insulin based on the estimated amount calculated from that time on previous days, and also gave correction doses of insulin or glucagon based on manually entered fingerstick plasma glucose data.
During the control period, adults lived at home as usual, managing their diabetes with their own insulin pump, the investigators said. They wore the G4 Platinum monitor with alarms deactivated and the blood glucose level masked, kept diaries of exercise, hypoglycemic episodes, and carbohydrate interventions, received a food allowance, and were encouraged to eat at restaurants. Adolescents lived at the diabetes summer camp alongside teenagers who were not part of the study, and also wore the masked device during the control period, said Dr. Russell and his associates.
In addition to the difference in mean glucose levels, adults had 67% less time with low glucose readings on the bionic pancreas than on the insulin pump (4.1% vs. 7.3% of the time), the researchers said. Adolescents had a 50% decrease in the amount of carbohydrates given to treat hypoglycemia, but no significant difference in amount of time with low glucose readings, which the researcher said might be because the summer camp rapidly responded to hypoglycemic episodes.
Adults had no severe hypoglycemic events, but during the bionic pancreas period, two had nausea and one vomited within 2 hours after a glucagon dose, and four had infusion sets removed because of pain or swelling, said the investigators. Adolescents had no severe hypoglycemia during the bionic pancreas period, they said, but during the control period, one patient became confused and hypoglycemic.
The slow absorption of available rapid-acting subcutaneous insulin analogues and the poor stability of current glucagon formulations are challenges in designing these devices, according to Dr. Russell and associates. "Since a single device that integrates all the components of a bionic pancreas is not yet available, we had to rely on wireless connectivity to the insulin and glucagon pumps, which was not completely reliable," they wrote, adding that the device could overestimate blood glucose level if patients take acetaminophen. "The balance of risks and benefits associated with delivering more insulin to achieve more physiologic glycemic control will require further study," they added, noting that the long-term safety of small peripheral doses of glucagon also is unknown.
The National Institute of Diabetes and Digestive and Kidney Diseases, the Leona M. and Harry B. Helmsley Charitable Trust, the Earle Charlton Fund for Innovative Research in Diabetes, the Frederick Banting Foundation, and Ralph Faber and John Whitlock funded the study. Three authors have patents or pending patents for blood glucose control systems. Dr. Russell and one co-author reported receiving fees from Medtronic, Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care, Biodel, and Dexcom.
A bionic insulin-glucagon pancreas achieved significantly better glycemic control than insulin pump therapy in adults and adolescents with type 1 diabetes, researchers reported at the annual scientific sessions of the American Diabetes Association.
The testing conditions in the two 5-day random-order crossover studies "simulated real-world outpatient settings with close monitoring for safety in adults and adolescents. Meals and physical activity were not regulated, in contrast with previous studies," wrote Dr. Stephen Russell at Massachusetts General Hospital and Harvard Medical School in Boston and his associates in a report published simultaneously with the presentation (N. Engl. J. Med. 2014 June 15 [doi: 10.1056/NEJMoa1314474]).
Adults achieved significantly lower mean plasma glucose levels during the bionic-pancreas period compared with the control period (7.4 vs. 8.8 mg/dL), as did adolescents (7.7 vs. 8.7 mg/dL), the investigators said. And differences were significant even though about 75% of patients had better baseline glycemic control than national averages, they said.
The studies included 20 adults from the Beacon Hill Study and 32 adolescents from the Summer Camp Study, said investigators. The bionic pancreas device included an Apple iPhone 4S, whose control algorithm received continuous glucose monitoring data and triggered dosing every 5 minutes, and a G4 Platinum continuous glucose monitor from Dexcom connected to the iPhone by a hardware interface. The device’s user interface showed continuous glucose readings and insulin and glucagon doses, and enabled the wearer to record meal sizes as typical, more than usual, less than usual, or a "small bite." Based on meal size, the device adapted the insulin dose to meet 75% of the estimated 4-hour postprandial need. If the glucose sensor failed, the device automatically delivered insulin based on the estimated amount calculated from that time on previous days, and also gave correction doses of insulin or glucagon based on manually entered fingerstick plasma glucose data.
During the control period, adults lived at home as usual, managing their diabetes with their own insulin pump, the investigators said. They wore the G4 Platinum monitor with alarms deactivated and the blood glucose level masked, kept diaries of exercise, hypoglycemic episodes, and carbohydrate interventions, received a food allowance, and were encouraged to eat at restaurants. Adolescents lived at the diabetes summer camp alongside teenagers who were not part of the study, and also wore the masked device during the control period, said Dr. Russell and his associates.
In addition to the difference in mean glucose levels, adults had 67% less time with low glucose readings on the bionic pancreas than on the insulin pump (4.1% vs. 7.3% of the time), the researchers said. Adolescents had a 50% decrease in the amount of carbohydrates given to treat hypoglycemia, but no significant difference in amount of time with low glucose readings, which the researcher said might be because the summer camp rapidly responded to hypoglycemic episodes.
Adults had no severe hypoglycemic events, but during the bionic pancreas period, two had nausea and one vomited within 2 hours after a glucagon dose, and four had infusion sets removed because of pain or swelling, said the investigators. Adolescents had no severe hypoglycemia during the bionic pancreas period, they said, but during the control period, one patient became confused and hypoglycemic.
The slow absorption of available rapid-acting subcutaneous insulin analogues and the poor stability of current glucagon formulations are challenges in designing these devices, according to Dr. Russell and associates. "Since a single device that integrates all the components of a bionic pancreas is not yet available, we had to rely on wireless connectivity to the insulin and glucagon pumps, which was not completely reliable," they wrote, adding that the device could overestimate blood glucose level if patients take acetaminophen. "The balance of risks and benefits associated with delivering more insulin to achieve more physiologic glycemic control will require further study," they added, noting that the long-term safety of small peripheral doses of glucagon also is unknown.
The National Institute of Diabetes and Digestive and Kidney Diseases, the Leona M. and Harry B. Helmsley Charitable Trust, the Earle Charlton Fund for Innovative Research in Diabetes, the Frederick Banting Foundation, and Ralph Faber and John Whitlock funded the study. Three authors have patents or pending patents for blood glucose control systems. Dr. Russell and one co-author reported receiving fees from Medtronic, Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care, Biodel, and Dexcom.
A bionic insulin-glucagon pancreas achieved significantly better glycemic control than insulin pump therapy in adults and adolescents with type 1 diabetes, researchers reported at the annual scientific sessions of the American Diabetes Association.
The testing conditions in the two 5-day random-order crossover studies "simulated real-world outpatient settings with close monitoring for safety in adults and adolescents. Meals and physical activity were not regulated, in contrast with previous studies," wrote Dr. Stephen Russell at Massachusetts General Hospital and Harvard Medical School in Boston and his associates in a report published simultaneously with the presentation (N. Engl. J. Med. 2014 June 15 [doi: 10.1056/NEJMoa1314474]).
Adults achieved significantly lower mean plasma glucose levels during the bionic-pancreas period compared with the control period (7.4 vs. 8.8 mg/dL), as did adolescents (7.7 vs. 8.7 mg/dL), the investigators said. And differences were significant even though about 75% of patients had better baseline glycemic control than national averages, they said.
The studies included 20 adults from the Beacon Hill Study and 32 adolescents from the Summer Camp Study, said investigators. The bionic pancreas device included an Apple iPhone 4S, whose control algorithm received continuous glucose monitoring data and triggered dosing every 5 minutes, and a G4 Platinum continuous glucose monitor from Dexcom connected to the iPhone by a hardware interface. The device’s user interface showed continuous glucose readings and insulin and glucagon doses, and enabled the wearer to record meal sizes as typical, more than usual, less than usual, or a "small bite." Based on meal size, the device adapted the insulin dose to meet 75% of the estimated 4-hour postprandial need. If the glucose sensor failed, the device automatically delivered insulin based on the estimated amount calculated from that time on previous days, and also gave correction doses of insulin or glucagon based on manually entered fingerstick plasma glucose data.
During the control period, adults lived at home as usual, managing their diabetes with their own insulin pump, the investigators said. They wore the G4 Platinum monitor with alarms deactivated and the blood glucose level masked, kept diaries of exercise, hypoglycemic episodes, and carbohydrate interventions, received a food allowance, and were encouraged to eat at restaurants. Adolescents lived at the diabetes summer camp alongside teenagers who were not part of the study, and also wore the masked device during the control period, said Dr. Russell and his associates.
In addition to the difference in mean glucose levels, adults had 67% less time with low glucose readings on the bionic pancreas than on the insulin pump (4.1% vs. 7.3% of the time), the researchers said. Adolescents had a 50% decrease in the amount of carbohydrates given to treat hypoglycemia, but no significant difference in amount of time with low glucose readings, which the researcher said might be because the summer camp rapidly responded to hypoglycemic episodes.
Adults had no severe hypoglycemic events, but during the bionic pancreas period, two had nausea and one vomited within 2 hours after a glucagon dose, and four had infusion sets removed because of pain or swelling, said the investigators. Adolescents had no severe hypoglycemia during the bionic pancreas period, they said, but during the control period, one patient became confused and hypoglycemic.
The slow absorption of available rapid-acting subcutaneous insulin analogues and the poor stability of current glucagon formulations are challenges in designing these devices, according to Dr. Russell and associates. "Since a single device that integrates all the components of a bionic pancreas is not yet available, we had to rely on wireless connectivity to the insulin and glucagon pumps, which was not completely reliable," they wrote, adding that the device could overestimate blood glucose level if patients take acetaminophen. "The balance of risks and benefits associated with delivering more insulin to achieve more physiologic glycemic control will require further study," they added, noting that the long-term safety of small peripheral doses of glucagon also is unknown.
The National Institute of Diabetes and Digestive and Kidney Diseases, the Leona M. and Harry B. Helmsley Charitable Trust, the Earle Charlton Fund for Innovative Research in Diabetes, the Frederick Banting Foundation, and Ralph Faber and John Whitlock funded the study. Three authors have patents or pending patents for blood glucose control systems. Dr. Russell and one co-author reported receiving fees from Medtronic, Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care, Biodel, and Dexcom.
FROM THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: A bihormonal bionic pancreas achieved better glycemic control than did insulin pump therapy.
Major finding: Patients with type 1 diabetes had significantly lower mean plasma glucose levels during the bionic-pancreas period than during the control period (133 vs. 159 mg/dL for adults; 138 vs. 157 mg/dL for adolescents).
Data source: Two 5-day, random-order crossover studies in 20 adults and 32 adolescents with type 1 diabetes. Researchers assessed glycemic control with a bihormonal automated bionic pancreas or with an insulin pump.
Disclosures: The NIDDK and several foundations funded the study. Three authors have patents or pending patents for blood glucose control systems. Dr. Russell and one co-author reported receiving fees from Medtronic, Tandem Diabetes, Sanofi Aventis, Eli Lilly, Abbott Diabetes Care, Biodel, and Dexcom.
Novel combination drug IDegLira boosts glycemic control
SAN FRANCISCO – The fixed-ratio combination of insulin degludec and the glucagonlike peptide-1 receptor agonist liraglutide improved glycemic control with a low risk of hypoglycemia across different weight groups, according to a post-hoc analysis of two phase III trials.
The investigational drug IDegLira also effectively reduced hemoglobin A1c (HbA1c) in both insulin-naive patients and in patients who were previously uncontrolled on basal insulin, Dr. John B. Buse reported at the annual scientific sessions of the American Diabetes Association.
Dr. Buse and his colleagues analyzed the phase III DUAL I and DUAL II trials to find the efficacy and safety of IDegLira across four body mass index (BMI) categories: less than 25 kg/m2; 25-30 kg/m2; 30-35 kg/m2; and more than 35 kg/m2.
DUAL I, a large open-label study of 1,600 insulin-naive patients with type 2 diabetes, compared IDegLira with insulin degludec (IDeg) and with liraglutide (Lira).
The DUAL II trial involved 400 patients and was designed to specifically study the contribution of liraglutide in IDegLira, compared with IDeg alone. Study participants had been on modest doses of insulin and had relatively uncontrolled diabetes.
The analysis showed that there was a consistent and significant HbA1c reduction across all baseline BMI categories in the DUAL I and DUAL II trials.
In DUAL I, IDegLira reduced HbA1c by 1.8%-1.9%. IDeg lowered HbA1c levels between 1.1% and 1.4%, and Lira reduced those levels between 1.1% and 1.3%.
The DUAL II results also showed similar significant reductions when IDegLira was compared with IDeg. "Relatively great efficacy of combination is maintained across the BMI categories," said Dr. Buse, professor of medicine, chief of the division of endocrinology and metabolism, and executive associate dean for clinical research at the University of North Carolina, Chapel Hill.
With IDegLira, there also were low rates of hypoglycemia across the four BMI categories in both trials.
The combination also reduced insulin requirement across BMI categories in DUAL I when IDegLira was compared with IDeg. In DUAL II, the insulin doses were equivalent for IDegLira and IDeg across the BMI categories, since titration was capped at 50 units to achieve identical exposure.
Previous studies on the combination of insulin with GLP-1 agonists have had uniformly encouraging results, showing less weight gain and in some cases better overall glucose control, said Dr. Matthew C. Riddle, professor of medicine at Oregon Health and Science University in Portland, who was not involved in the study.
Combination therapies do have some disadvantages, he said, and "you get potential side effects from GLP-1 agonists that you don’t get from insulin. But overall, the balance looks very favorable. So this is one in a series of studies that shows this is an attractive option for the future."
Dr. Buse is a consultant to Novo Nordisk and more than 30 other pharmaceutical companies. Dr. Riddle said that he is a consultant for several companies, including Novo Nordisk.
On Twitter @naseemmiller
phase III DUAL I and DUAL II trials, insulin-naive patients with type 2 diabetes, insulin degludec, IDeg, liraglutide, Lira, HbA1c reduction,
SAN FRANCISCO – The fixed-ratio combination of insulin degludec and the glucagonlike peptide-1 receptor agonist liraglutide improved glycemic control with a low risk of hypoglycemia across different weight groups, according to a post-hoc analysis of two phase III trials.
The investigational drug IDegLira also effectively reduced hemoglobin A1c (HbA1c) in both insulin-naive patients and in patients who were previously uncontrolled on basal insulin, Dr. John B. Buse reported at the annual scientific sessions of the American Diabetes Association.
Dr. Buse and his colleagues analyzed the phase III DUAL I and DUAL II trials to find the efficacy and safety of IDegLira across four body mass index (BMI) categories: less than 25 kg/m2; 25-30 kg/m2; 30-35 kg/m2; and more than 35 kg/m2.
DUAL I, a large open-label study of 1,600 insulin-naive patients with type 2 diabetes, compared IDegLira with insulin degludec (IDeg) and with liraglutide (Lira).
The DUAL II trial involved 400 patients and was designed to specifically study the contribution of liraglutide in IDegLira, compared with IDeg alone. Study participants had been on modest doses of insulin and had relatively uncontrolled diabetes.
The analysis showed that there was a consistent and significant HbA1c reduction across all baseline BMI categories in the DUAL I and DUAL II trials.
In DUAL I, IDegLira reduced HbA1c by 1.8%-1.9%. IDeg lowered HbA1c levels between 1.1% and 1.4%, and Lira reduced those levels between 1.1% and 1.3%.
The DUAL II results also showed similar significant reductions when IDegLira was compared with IDeg. "Relatively great efficacy of combination is maintained across the BMI categories," said Dr. Buse, professor of medicine, chief of the division of endocrinology and metabolism, and executive associate dean for clinical research at the University of North Carolina, Chapel Hill.
With IDegLira, there also were low rates of hypoglycemia across the four BMI categories in both trials.
The combination also reduced insulin requirement across BMI categories in DUAL I when IDegLira was compared with IDeg. In DUAL II, the insulin doses were equivalent for IDegLira and IDeg across the BMI categories, since titration was capped at 50 units to achieve identical exposure.
Previous studies on the combination of insulin with GLP-1 agonists have had uniformly encouraging results, showing less weight gain and in some cases better overall glucose control, said Dr. Matthew C. Riddle, professor of medicine at Oregon Health and Science University in Portland, who was not involved in the study.
Combination therapies do have some disadvantages, he said, and "you get potential side effects from GLP-1 agonists that you don’t get from insulin. But overall, the balance looks very favorable. So this is one in a series of studies that shows this is an attractive option for the future."
Dr. Buse is a consultant to Novo Nordisk and more than 30 other pharmaceutical companies. Dr. Riddle said that he is a consultant for several companies, including Novo Nordisk.
On Twitter @naseemmiller
SAN FRANCISCO – The fixed-ratio combination of insulin degludec and the glucagonlike peptide-1 receptor agonist liraglutide improved glycemic control with a low risk of hypoglycemia across different weight groups, according to a post-hoc analysis of two phase III trials.
The investigational drug IDegLira also effectively reduced hemoglobin A1c (HbA1c) in both insulin-naive patients and in patients who were previously uncontrolled on basal insulin, Dr. John B. Buse reported at the annual scientific sessions of the American Diabetes Association.
Dr. Buse and his colleagues analyzed the phase III DUAL I and DUAL II trials to find the efficacy and safety of IDegLira across four body mass index (BMI) categories: less than 25 kg/m2; 25-30 kg/m2; 30-35 kg/m2; and more than 35 kg/m2.
DUAL I, a large open-label study of 1,600 insulin-naive patients with type 2 diabetes, compared IDegLira with insulin degludec (IDeg) and with liraglutide (Lira).
The DUAL II trial involved 400 patients and was designed to specifically study the contribution of liraglutide in IDegLira, compared with IDeg alone. Study participants had been on modest doses of insulin and had relatively uncontrolled diabetes.
The analysis showed that there was a consistent and significant HbA1c reduction across all baseline BMI categories in the DUAL I and DUAL II trials.
In DUAL I, IDegLira reduced HbA1c by 1.8%-1.9%. IDeg lowered HbA1c levels between 1.1% and 1.4%, and Lira reduced those levels between 1.1% and 1.3%.
The DUAL II results also showed similar significant reductions when IDegLira was compared with IDeg. "Relatively great efficacy of combination is maintained across the BMI categories," said Dr. Buse, professor of medicine, chief of the division of endocrinology and metabolism, and executive associate dean for clinical research at the University of North Carolina, Chapel Hill.
With IDegLira, there also were low rates of hypoglycemia across the four BMI categories in both trials.
The combination also reduced insulin requirement across BMI categories in DUAL I when IDegLira was compared with IDeg. In DUAL II, the insulin doses were equivalent for IDegLira and IDeg across the BMI categories, since titration was capped at 50 units to achieve identical exposure.
Previous studies on the combination of insulin with GLP-1 agonists have had uniformly encouraging results, showing less weight gain and in some cases better overall glucose control, said Dr. Matthew C. Riddle, professor of medicine at Oregon Health and Science University in Portland, who was not involved in the study.
Combination therapies do have some disadvantages, he said, and "you get potential side effects from GLP-1 agonists that you don’t get from insulin. But overall, the balance looks very favorable. So this is one in a series of studies that shows this is an attractive option for the future."
Dr. Buse is a consultant to Novo Nordisk and more than 30 other pharmaceutical companies. Dr. Riddle said that he is a consultant for several companies, including Novo Nordisk.
On Twitter @naseemmiller
phase III DUAL I and DUAL II trials, insulin-naive patients with type 2 diabetes, insulin degludec, IDeg, liraglutide, Lira, HbA1c reduction,
phase III DUAL I and DUAL II trials, insulin-naive patients with type 2 diabetes, insulin degludec, IDeg, liraglutide, Lira, HbA1c reduction,
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Combining insulin with GLP-1 receptor agonists continues to be an attractive therapeutic option for patients across BMI categories with uncontrolled diabetes.
Major finding: The investigational drug IDegLira effectively reduced HbA1c in both insulin-naive patients and in patients who previously were uncontrolled on basal insulin.
Data source: Post-hoc analysis of phase III DUAL I and DUAL II trials.
Disclosures: Dr. Buse is a consultant to Novo Nordisk and more than 30 other pharmaceutical companies. Dr. Riddle said that he is a consultant for several companies, including Novo Nordisk.
VIDEO: Teen brain reacts to sugar differently
SAN FRANCISCO — When it comes to glucose ingestion, the adolescent brain reacts differently than the adult brain. That’s according to functional MRI scans comparing the cerebral blood flow of lean adolescents with lean adults, Dr. Ania M. Jastreboff reported June 15 at the annual scientific sessions of the American Diabetes Association.
Researchers found that lean adolescents showed increased cerebral blood flow in several regions, including the reward-motivation region (striatum), the impulse control region (anterior cingulate cortex), and the prefrontal cortex, which is in charge of executive function regulation. All these regions undergo marked developmental changes during adolescence.
In a video interview, Dr. Jastreboff, assistant professor of internal medicine and pediatrics at Yale University, New Haven, Conn., further explains the study’s findings and its implications.
On Twitter @naseemmiller
SAN FRANCISCO — When it comes to glucose ingestion, the adolescent brain reacts differently than the adult brain. That’s according to functional MRI scans comparing the cerebral blood flow of lean adolescents with lean adults, Dr. Ania M. Jastreboff reported June 15 at the annual scientific sessions of the American Diabetes Association.
Researchers found that lean adolescents showed increased cerebral blood flow in several regions, including the reward-motivation region (striatum), the impulse control region (anterior cingulate cortex), and the prefrontal cortex, which is in charge of executive function regulation. All these regions undergo marked developmental changes during adolescence.
In a video interview, Dr. Jastreboff, assistant professor of internal medicine and pediatrics at Yale University, New Haven, Conn., further explains the study’s findings and its implications.
On Twitter @naseemmiller
SAN FRANCISCO — When it comes to glucose ingestion, the adolescent brain reacts differently than the adult brain. That’s according to functional MRI scans comparing the cerebral blood flow of lean adolescents with lean adults, Dr. Ania M. Jastreboff reported June 15 at the annual scientific sessions of the American Diabetes Association.
Researchers found that lean adolescents showed increased cerebral blood flow in several regions, including the reward-motivation region (striatum), the impulse control region (anterior cingulate cortex), and the prefrontal cortex, which is in charge of executive function regulation. All these regions undergo marked developmental changes during adolescence.
In a video interview, Dr. Jastreboff, assistant professor of internal medicine and pediatrics at Yale University, New Haven, Conn., further explains the study’s findings and its implications.
On Twitter @naseemmiller
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
VIDEO: ACC/AHA lipid guidelines and diabetes
SAN FRANCISCO – Those looking for guidance from the American Diabetes Association regarding the guidelines released last fall from the American College of Cardiology and the American Heart Association dropping cholesterol treatment goals will have to wait until next year.
That’s when the ADA’s Clinical Practice Recommendations, released each year in January, will incorporate the Professional Practice Committee’s review of the ACC/AHA guidelines and the evidence behind it. The new recommendations caused some controversy and raised some questions about treatment of certain patient groups, most notably those with diabetes.
The ADA hasn’t recommended any changes to its current guidelines, which still incorporate treatment to target. But it has been reviewing the guidelines to see if it would recommend any changes for its 2015 guidelines.
Dr. Robert E. Ratner, chief scientific and medical officer for the American Diabetes Association, further explained the organization’s position on treatment of lipids in patients with diabetes in a video interview at the annual scientific sessions of the ADA.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The association is also holding a debate at this year’s meeting to discuss the pros and cons of the new lipid guidelines for patients with diabetes.
In a press conference, Dr. Robert Eckel, professor of medicine and Charles A. Boettcher chair in atherosclerosis at University of Colorado, Anschutz Medical Campus, Aurora, said he was in support of the ACC/AHA guidelines, having served on the Task Force on Practice Guidelines, and that he believed that almost all patients with diabetes should be on a statin. He stressed that the new guidelines are evidence based.
But Dr. Henry Ginsberg, Irving Professor of Medicine and Director of the Irving Institute for Clinical and Translational Research at Columbia University, New York, argued that the guidelines’ evidence-based construct was too narrow.
In a video interview, Dr. Ginsberg further discussed his position and his practice tips for physicians.
Both physicians agreed that patients should be treated on an individual basis. For instance, patients who are statin intolerant won’t meet the guidelines’ criteria and "we’ll have to go beyond the guidelines," said Dr. Eckel.
On Twitter @naseemmiller
SAN FRANCISCO – Those looking for guidance from the American Diabetes Association regarding the guidelines released last fall from the American College of Cardiology and the American Heart Association dropping cholesterol treatment goals will have to wait until next year.
That’s when the ADA’s Clinical Practice Recommendations, released each year in January, will incorporate the Professional Practice Committee’s review of the ACC/AHA guidelines and the evidence behind it. The new recommendations caused some controversy and raised some questions about treatment of certain patient groups, most notably those with diabetes.
The ADA hasn’t recommended any changes to its current guidelines, which still incorporate treatment to target. But it has been reviewing the guidelines to see if it would recommend any changes for its 2015 guidelines.
Dr. Robert E. Ratner, chief scientific and medical officer for the American Diabetes Association, further explained the organization’s position on treatment of lipids in patients with diabetes in a video interview at the annual scientific sessions of the ADA.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The association is also holding a debate at this year’s meeting to discuss the pros and cons of the new lipid guidelines for patients with diabetes.
In a press conference, Dr. Robert Eckel, professor of medicine and Charles A. Boettcher chair in atherosclerosis at University of Colorado, Anschutz Medical Campus, Aurora, said he was in support of the ACC/AHA guidelines, having served on the Task Force on Practice Guidelines, and that he believed that almost all patients with diabetes should be on a statin. He stressed that the new guidelines are evidence based.
But Dr. Henry Ginsberg, Irving Professor of Medicine and Director of the Irving Institute for Clinical and Translational Research at Columbia University, New York, argued that the guidelines’ evidence-based construct was too narrow.
In a video interview, Dr. Ginsberg further discussed his position and his practice tips for physicians.
Both physicians agreed that patients should be treated on an individual basis. For instance, patients who are statin intolerant won’t meet the guidelines’ criteria and "we’ll have to go beyond the guidelines," said Dr. Eckel.
On Twitter @naseemmiller
SAN FRANCISCO – Those looking for guidance from the American Diabetes Association regarding the guidelines released last fall from the American College of Cardiology and the American Heart Association dropping cholesterol treatment goals will have to wait until next year.
That’s when the ADA’s Clinical Practice Recommendations, released each year in January, will incorporate the Professional Practice Committee’s review of the ACC/AHA guidelines and the evidence behind it. The new recommendations caused some controversy and raised some questions about treatment of certain patient groups, most notably those with diabetes.
The ADA hasn’t recommended any changes to its current guidelines, which still incorporate treatment to target. But it has been reviewing the guidelines to see if it would recommend any changes for its 2015 guidelines.
Dr. Robert E. Ratner, chief scientific and medical officer for the American Diabetes Association, further explained the organization’s position on treatment of lipids in patients with diabetes in a video interview at the annual scientific sessions of the ADA.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The association is also holding a debate at this year’s meeting to discuss the pros and cons of the new lipid guidelines for patients with diabetes.
In a press conference, Dr. Robert Eckel, professor of medicine and Charles A. Boettcher chair in atherosclerosis at University of Colorado, Anschutz Medical Campus, Aurora, said he was in support of the ACC/AHA guidelines, having served on the Task Force on Practice Guidelines, and that he believed that almost all patients with diabetes should be on a statin. He stressed that the new guidelines are evidence based.
But Dr. Henry Ginsberg, Irving Professor of Medicine and Director of the Irving Institute for Clinical and Translational Research at Columbia University, New York, argued that the guidelines’ evidence-based construct was too narrow.
In a video interview, Dr. Ginsberg further discussed his position and his practice tips for physicians.
Both physicians agreed that patients should be treated on an individual basis. For instance, patients who are statin intolerant won’t meet the guidelines’ criteria and "we’ll have to go beyond the guidelines," said Dr. Eckel.
On Twitter @naseemmiller
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Diabetes risk declines as diet quality improves
SAN FRANCISCO – Even small improvements to the quality of diet can help stave off diabetes.
More specifically, adults whose diet quality scores improved by at least 10% were 9% less likely to develop type 2 diabetes in the next 4 years, and those whose diet quality scores worsened by at least 10% were 18% more likely to develop diabetes, according to an analysis of data from three longitudinal observational studies involving 184,417 people.
Those changes in diabetes risk were statistically significant, Sylvia H. Ley, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.
They analyzed data on participants in the Nurses Health Study I, Nurses Health Study II, and the Health Professionals Follow-Up Study who were followed for at least 20 years in each study and asked every 2 years about incident diabetes and every 4 years about the contents of their diet, among other topics. Dr. Ley and her associates used the Alternative Healthy Eating Index to assess diet quality.
Nearly 10,000 new cases of type 2 diabetes were reported during more than 2 million person-years of follow-up, Dr. Ley of Harvard University’s School of Public Health, Boston, said in a press briefing.
The associations between dietary changes and diabetes risk affected all people, whether they ate well or poorly, according to subset analyses of participants grouped as those having the poorest quality diet, medium quality, or highest quality diet. "Regardless of where you start, improving your diet quality is helpful in diabetes prevention," Dr. Ley said.
The reduced diabetes risk from improving diet quality was independent of effects from physical activity or reduced body weight, she said.
The Alternative Healthy Eating Index focused on intake of 11 components: red meat, nuts, sugar-sweetened beverages, fruits, vegetables, polyunsaturated fat, trans fat, omega fats, alcohol, sodium, and whole grains, with up to 10 points for intake of each. A perfect diet score was 110, so a mere 11-point gain provided a 10% improvement in diet quality, she said.
A 10% improvement in diet quality is "not that difficult" to make, Dr. Ley said. Nearly everyone in the study started with a poor-quality diet, and many made more than a 10% improvement in diet quality scores.
The bottom line is that changing one’s diet can be helpful, she said. "I think healthy eating is somewhat abstract, and that people still have difficulty understanding what that means," Dr. Ley said. "I think it’s helpful to provide more information on what is healthy and what is better quality eating."
A separate study by Dr. Ley and her associates found that the quality of foods and drinks consumed is more important than the quantity and that a number of different dietary strategies can reduce diabetes risk (including a Mediterranean diet, vegetarian diet, low-glycemic-index diet, or moderately low carbohydrate diet) because they are rich in whole grains, fruits, vegetables, legumes, and nuts, with moderate to low amounts of alcohol, refined grains, red or processed meats, and sugar-sweetened beverages (Lancet 2014;383:1999-2007).
Other previous randomized, controlled studies had shown that restricting dietary calories can help protect against development of diabetes, but that dietary strategy is difficult for people to maintain, Dr. Ley said. "That has led us to take more food-based approaches," she said. In addition, those studies predominantly looked at people who were at high risk for diabetes, whereas the current study looked at a normal healthy population.
The current findings can’t be generalized to the entire population without further study, however, because participants in the three studies in the analysis were relatively well-educated health care professionals and 98% were white.
Dr. Ley reported having no financial disclosures.
On Twitter @sherryboschert
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Isn’t it great to have more science to prove what we think makes a lot of sense? If we dig a little deeper, the study raises questions. How are we measuring quality? If we can get clear guidelines out to people about what we mean by quality nutrition, that would help. I think that would mean more fruits and vegetables, more whole grains, lower saturated-fat protein sources, and lower-fat dairy sources. Getting real clarity on what that message is, and how to translate to the general population what exactly to eat, would be progress.
Melinda Marynuik, M.Ed., R.D., C.D.E., is director of clinical education programs at Joslin Diabetes Center, Boston. She disclosed having no financial conflicts.
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Isn’t it great to have more science to prove what we think makes a lot of sense? If we dig a little deeper, the study raises questions. How are we measuring quality? If we can get clear guidelines out to people about what we mean by quality nutrition, that would help. I think that would mean more fruits and vegetables, more whole grains, lower saturated-fat protein sources, and lower-fat dairy sources. Getting real clarity on what that message is, and how to translate to the general population what exactly to eat, would be progress.
Melinda Marynuik, M.Ed., R.D., C.D.E., is director of clinical education programs at Joslin Diabetes Center, Boston. She disclosed having no financial conflicts.
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|
Isn’t it great to have more science to prove what we think makes a lot of sense? If we dig a little deeper, the study raises questions. How are we measuring quality? If we can get clear guidelines out to people about what we mean by quality nutrition, that would help. I think that would mean more fruits and vegetables, more whole grains, lower saturated-fat protein sources, and lower-fat dairy sources. Getting real clarity on what that message is, and how to translate to the general population what exactly to eat, would be progress.
Melinda Marynuik, M.Ed., R.D., C.D.E., is director of clinical education programs at Joslin Diabetes Center, Boston. She disclosed having no financial conflicts.
SAN FRANCISCO – Even small improvements to the quality of diet can help stave off diabetes.
More specifically, adults whose diet quality scores improved by at least 10% were 9% less likely to develop type 2 diabetes in the next 4 years, and those whose diet quality scores worsened by at least 10% were 18% more likely to develop diabetes, according to an analysis of data from three longitudinal observational studies involving 184,417 people.
Those changes in diabetes risk were statistically significant, Sylvia H. Ley, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.
They analyzed data on participants in the Nurses Health Study I, Nurses Health Study II, and the Health Professionals Follow-Up Study who were followed for at least 20 years in each study and asked every 2 years about incident diabetes and every 4 years about the contents of their diet, among other topics. Dr. Ley and her associates used the Alternative Healthy Eating Index to assess diet quality.
Nearly 10,000 new cases of type 2 diabetes were reported during more than 2 million person-years of follow-up, Dr. Ley of Harvard University’s School of Public Health, Boston, said in a press briefing.
The associations between dietary changes and diabetes risk affected all people, whether they ate well or poorly, according to subset analyses of participants grouped as those having the poorest quality diet, medium quality, or highest quality diet. "Regardless of where you start, improving your diet quality is helpful in diabetes prevention," Dr. Ley said.
The reduced diabetes risk from improving diet quality was independent of effects from physical activity or reduced body weight, she said.
The Alternative Healthy Eating Index focused on intake of 11 components: red meat, nuts, sugar-sweetened beverages, fruits, vegetables, polyunsaturated fat, trans fat, omega fats, alcohol, sodium, and whole grains, with up to 10 points for intake of each. A perfect diet score was 110, so a mere 11-point gain provided a 10% improvement in diet quality, she said.
A 10% improvement in diet quality is "not that difficult" to make, Dr. Ley said. Nearly everyone in the study started with a poor-quality diet, and many made more than a 10% improvement in diet quality scores.
The bottom line is that changing one’s diet can be helpful, she said. "I think healthy eating is somewhat abstract, and that people still have difficulty understanding what that means," Dr. Ley said. "I think it’s helpful to provide more information on what is healthy and what is better quality eating."
A separate study by Dr. Ley and her associates found that the quality of foods and drinks consumed is more important than the quantity and that a number of different dietary strategies can reduce diabetes risk (including a Mediterranean diet, vegetarian diet, low-glycemic-index diet, or moderately low carbohydrate diet) because they are rich in whole grains, fruits, vegetables, legumes, and nuts, with moderate to low amounts of alcohol, refined grains, red or processed meats, and sugar-sweetened beverages (Lancet 2014;383:1999-2007).
Other previous randomized, controlled studies had shown that restricting dietary calories can help protect against development of diabetes, but that dietary strategy is difficult for people to maintain, Dr. Ley said. "That has led us to take more food-based approaches," she said. In addition, those studies predominantly looked at people who were at high risk for diabetes, whereas the current study looked at a normal healthy population.
The current findings can’t be generalized to the entire population without further study, however, because participants in the three studies in the analysis were relatively well-educated health care professionals and 98% were white.
Dr. Ley reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Even small improvements to the quality of diet can help stave off diabetes.
More specifically, adults whose diet quality scores improved by at least 10% were 9% less likely to develop type 2 diabetes in the next 4 years, and those whose diet quality scores worsened by at least 10% were 18% more likely to develop diabetes, according to an analysis of data from three longitudinal observational studies involving 184,417 people.
Those changes in diabetes risk were statistically significant, Sylvia H. Ley, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.
They analyzed data on participants in the Nurses Health Study I, Nurses Health Study II, and the Health Professionals Follow-Up Study who were followed for at least 20 years in each study and asked every 2 years about incident diabetes and every 4 years about the contents of their diet, among other topics. Dr. Ley and her associates used the Alternative Healthy Eating Index to assess diet quality.
Nearly 10,000 new cases of type 2 diabetes were reported during more than 2 million person-years of follow-up, Dr. Ley of Harvard University’s School of Public Health, Boston, said in a press briefing.
The associations between dietary changes and diabetes risk affected all people, whether they ate well or poorly, according to subset analyses of participants grouped as those having the poorest quality diet, medium quality, or highest quality diet. "Regardless of where you start, improving your diet quality is helpful in diabetes prevention," Dr. Ley said.
The reduced diabetes risk from improving diet quality was independent of effects from physical activity or reduced body weight, she said.
The Alternative Healthy Eating Index focused on intake of 11 components: red meat, nuts, sugar-sweetened beverages, fruits, vegetables, polyunsaturated fat, trans fat, omega fats, alcohol, sodium, and whole grains, with up to 10 points for intake of each. A perfect diet score was 110, so a mere 11-point gain provided a 10% improvement in diet quality, she said.
A 10% improvement in diet quality is "not that difficult" to make, Dr. Ley said. Nearly everyone in the study started with a poor-quality diet, and many made more than a 10% improvement in diet quality scores.
The bottom line is that changing one’s diet can be helpful, she said. "I think healthy eating is somewhat abstract, and that people still have difficulty understanding what that means," Dr. Ley said. "I think it’s helpful to provide more information on what is healthy and what is better quality eating."
A separate study by Dr. Ley and her associates found that the quality of foods and drinks consumed is more important than the quantity and that a number of different dietary strategies can reduce diabetes risk (including a Mediterranean diet, vegetarian diet, low-glycemic-index diet, or moderately low carbohydrate diet) because they are rich in whole grains, fruits, vegetables, legumes, and nuts, with moderate to low amounts of alcohol, refined grains, red or processed meats, and sugar-sweetened beverages (Lancet 2014;383:1999-2007).
Other previous randomized, controlled studies had shown that restricting dietary calories can help protect against development of diabetes, but that dietary strategy is difficult for people to maintain, Dr. Ley said. "That has led us to take more food-based approaches," she said. In addition, those studies predominantly looked at people who were at high risk for diabetes, whereas the current study looked at a normal healthy population.
The current findings can’t be generalized to the entire population without further study, however, because participants in the three studies in the analysis were relatively well-educated health care professionals and 98% were white.
Dr. Ley reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: No matter how you eat now, improving diet quality is significantly associated with reduced risk for diabetes.
Major finding: Improving diet quality by 10% or more was associated with a 9% lower risk for type 2 diabetes, and worsening diet quality by 10% or more was associated with an 18% increase in risk.
Data source: Analysis of longitudinal data on 184,417 health care workers from three prospective observational studies.
Disclosures: Dr. Ley reported having no financial disclosures.
