Pooled Data Analysis of Canagliflozin

Chicago—Compared with a group receiving placebo, patients with type 2 diabetes who took 100 mg or 300 mg of canagliflozin had improvements in glycemic control and reductions in body weight, according to a pooled data analysis of 4 randomized, placebo-controlled trials. The findings were consistent for patients <65 years of age or ≥65 years of age.

Results were presented at the ADA meeting in a late-breaking poster session. The poster was titled Efficacy and Safety of Canagliflozin in Older Subjects with Type 2 Diabetes Mellitus.

In March 2013, the FDA approved canagliflozin for use with diet and exercise in patients with type 2 diabetes. Canagliflozin is an oral medication and the first FDA-approved drug in a new class known as sodium-glucose co-transporter 2 inhibitors.

Each of the trials in this analysis lasted 26 weeks. The studies included a total of 2313 patients who received placebo or canagliflozin as monotherapy, as an add-on to metformin, as an add-on to metformin plus sulfonylurea, and as an add-on to metformin plus pioglitazone. The canagliflozin doses were 100 mg or 300 mg taken once daily.

Patients were 18 to 80 years of age and had hemoglobin A1c (HbA1c) levels from 7.0% to 10.5% at baseline. At baseline, the groups were well balanced. Of the patients <65 years of age, approximately 50% were male, 70% were white, mean age was 53 years, and the mean duration of type 2 diabetes was 6.5 years. Of the patients ≥65 years of age, approximately 50% were male, 85% were white, mean age was 70 years, and mean duration of type 2 diabetes was 10 years.

Of the patients who were randomized, 85.8% finished the 26-week treatment period, including 85.9% of patients <65 years of age and 85.4% of patients ≥65 years of age.

After 26 weeks of treatment for patients <65 years of age, the mean reduction in HbA1c from baseline was 1.08% in the 300-mg canagliflozin group, 0.89% in the 100-mg canagliflozin group, and 0.15% in the placebo group. For patients ≥65 years of age, the mean reduction in HbA1c from baseline was 0.88% in the 300-mg canagliflozin group, 0.69% in the 100-mg canagliflozin group, and 0.05% in the placebo group.

In addition, for patients <65 years of age, the mean reduction in fasting plasma glucose (FPG) from baseline was 36.0 mg/dL in the 300-mg canagliflozin group and 27.0 mg/dL in the 100-mg canagliflozin group. The FPG increased by a mean of 4.4 mg/dL in the placebo group. For patients ≥65 years of age, the mean reduction in FPG from baseline was 33.1 mg/dL in the 300-mg canagliflozin group and 20.4 mg/dL in the 100-mg canagliflozin group. The FPG increased by a mean of 1.6 mg/dL in the placebo group.

Further, for patients <65 years of age, the mean reduction in body weight from baseline was 3.4 kg in the 300-mg canagliflozin group, 2.8 kg in the 100-mg canagliflozin group, and 0.6 kg in the placebo group. For patients ≥65 years of age, the mean reduction in body weight from baseline was 3.8 kg in the 300-mg canagliflozin group, 2.9 kg in the 100-mg canagliflozin group, and 0.6 kg in the placebo group.

The authors noted that patients in each age category tolerated both doses of canagliflozin, although there were higher rates of genital mycotic infections and osmotic diuresis-related adverse events among patients taking canagliflozin compared with those receiving placebo.

Janssen Research & Development, LLC supported this study.