Canagliflozin effects include weight loss in phase III placebo-controlled trial

Treatment with canagliflozin was associated with significant weight loss as well as improvements in glycemic control, when compared with placebo in a 26-week, phase III study of nearly 600 patients.

Dr. William Canovatchel of Janssen Pharmaceuticals, the manufacturer of canagliflozin, is presenting these results on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

In phase III clinical trials, canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, has been associated with significant weight loss in a variety of patients, he noted. In the phase III randomized, placebo-controlled study, 584 patients with type 2 diabetes who were inadequately treated with diet and exercise were randomized to placebo or canagliflozin (300 mg or 100 mg once a day). The mean age was 55 years, and the patients’ mean hemoglobin A_1c was 8%. Their mean body weight was 191 pounds (86.8 kg).

At 26 weeks, the mean reductions in HbA_1c from baseline (the primary endpoint) among patients on the 100-mg and 300-mg doses of canagliflozin were 0.77% and 1.03%, respectively, compared with an increase of 0.14% among those on placebo. Differences between the drug and placebo were statistically significant.

In addition, those on the 100-mg and 300-mg canagliflozin doses lost a mean of 5.5 pounds (2.5 kg), and 7.5 pounds (3.4 kg), respectively, compared with a mean of 1 pound (0.5 kg) among those on placebo.

Moreover, 71% of those on 100 mg and 84% of those on 300 mg had reductions in both weight and HbA_1c, compared with 28% of those on placebo, according to Dr. Canovatchel.

Genital mycotic infections, urinary tract infections, and those related to osmotic diuresis were among the adverse events associated with canagliflozin, which was generally well tolerated, he said. The drug was associated with a low rate of hypoglycemia.

Canagliflozin (Invokana) was the first SGLT2 inhibitor to be approved in the United States, in March 2013. These agents, taken orally, work by inhibiting SGLT2 that is expressed in the kidney, reducing renal glucose reabsorption, increasing urinary excretion of glucose, and reducing plasma glucose levels.

The study was published last year (Diabetes Obes. Metab. 2013;15:372-82).

Dr. Canovatchel is an employee of Janssen, the manufacturer of canagliflozin.

emechcatie@frontlinemedcom.com

Treatment with canagliflozin was associated with significant weight loss as well as improvements in glycemic control, when compared with placebo in a 26-week, phase III study of nearly 600 patients.

Dr. William Canovatchel of Janssen Pharmaceuticals, the manufacturer of canagliflozin, is presenting these results on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

In phase III clinical trials, canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, has been associated with significant weight loss in a variety of patients, he noted. In the phase III randomized, placebo-controlled study, 584 patients with type 2 diabetes who were inadequately treated with diet and exercise were randomized to placebo or canagliflozin (300 mg or 100 mg once a day). The mean age was 55 years, and the patients’ mean hemoglobin A_1c was 8%. Their mean body weight was 191 pounds (86.8 kg).

At 26 weeks, the mean reductions in HbA_1c from baseline (the primary endpoint) among patients on the 100-mg and 300-mg doses of canagliflozin were 0.77% and 1.03%, respectively, compared with an increase of 0.14% among those on placebo. Differences between the drug and placebo were statistically significant.

In addition, those on the 100-mg and 300-mg canagliflozin doses lost a mean of 5.5 pounds (2.5 kg), and 7.5 pounds (3.4 kg), respectively, compared with a mean of 1 pound (0.5 kg) among those on placebo.

Moreover, 71% of those on 100 mg and 84% of those on 300 mg had reductions in both weight and HbA_1c, compared with 28% of those on placebo, according to Dr. Canovatchel.

Genital mycotic infections, urinary tract infections, and those related to osmotic diuresis were among the adverse events associated with canagliflozin, which was generally well tolerated, he said. The drug was associated with a low rate of hypoglycemia.

Canagliflozin (Invokana) was the first SGLT2 inhibitor to be approved in the United States, in March 2013. These agents, taken orally, work by inhibiting SGLT2 that is expressed in the kidney, reducing renal glucose reabsorption, increasing urinary excretion of glucose, and reducing plasma glucose levels.

The study was published last year (Diabetes Obes. Metab. 2013;15:372-82).

Dr. Canovatchel is an employee of Janssen, the manufacturer of canagliflozin.

emechcatie@frontlinemedcom.com

Treatment with canagliflozin was associated with significant weight loss as well as improvements in glycemic control, when compared with placebo in a 26-week, phase III study of nearly 600 patients.

Dr. William Canovatchel of Janssen Pharmaceuticals, the manufacturer of canagliflozin, is presenting these results on May 16 at the annual meeting of the American Association of Clinical Endocrinologists.

In phase III clinical trials, canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, has been associated with significant weight loss in a variety of patients, he noted. In the phase III randomized, placebo-controlled study, 584 patients with type 2 diabetes who were inadequately treated with diet and exercise were randomized to placebo or canagliflozin (300 mg or 100 mg once a day). The mean age was 55 years, and the patients’ mean hemoglobin A_1c was 8%. Their mean body weight was 191 pounds (86.8 kg).

At 26 weeks, the mean reductions in HbA_1c from baseline (the primary endpoint) among patients on the 100-mg and 300-mg doses of canagliflozin were 0.77% and 1.03%, respectively, compared with an increase of 0.14% among those on placebo. Differences between the drug and placebo were statistically significant.

In addition, those on the 100-mg and 300-mg canagliflozin doses lost a mean of 5.5 pounds (2.5 kg), and 7.5 pounds (3.4 kg), respectively, compared with a mean of 1 pound (0.5 kg) among those on placebo.

Moreover, 71% of those on 100 mg and 84% of those on 300 mg had reductions in both weight and HbA_1c, compared with 28% of those on placebo, according to Dr. Canovatchel.

Genital mycotic infections, urinary tract infections, and those related to osmotic diuresis were among the adverse events associated with canagliflozin, which was generally well tolerated, he said. The drug was associated with a low rate of hypoglycemia.

Canagliflozin (Invokana) was the first SGLT2 inhibitor to be approved in the United States, in March 2013. These agents, taken orally, work by inhibiting SGLT2 that is expressed in the kidney, reducing renal glucose reabsorption, increasing urinary excretion of glucose, and reducing plasma glucose levels.

The study was published last year (Diabetes Obes. Metab. 2013;15:372-82).

Dr. Canovatchel is an employee of Janssen, the manufacturer of canagliflozin.

emechcatie@frontlinemedcom.com