Canagliflozin: Phase III data

The double-blind, international Phase III DIA3015 trial in 755 Type II diabetics with inadequate glycemic control on maximally effective doses of metformin and sulfonylurea showed that once-daily 300 mg oral canagliflozin plus metformin and sulfonylurea met the primary endpoint of reducing HbA1c from baseline to week 52 vs. once-daily 100 mg Januvia sitagliptin plus metformin and sulfonylurea (1.03% vs. 0.66%). On secondary endpoints, canagliflozin led to significantly greater reductions in FPG (29.9 vs. 5.9 mg/dL), body weight (2.5% vs. a gain of 0.3%) and SBP (5.1 mmHg vs. a gain of 0.9 mmHg) vs. Januvia (p<0.001 for all). Additionally, a greater proportion of patients receiving canagliflozin achieved an HbA1c target of <7% vs. Januvia (47.6% vs. 35.3%).

Canagliflozin also increased HDL-C by 7.6%, LDL-C by 11.7% and triglycerides by 9.6% from baseline to week 52, while Januvia increased each endpoint by 0.6%, 5.2% and 11.9%, respectively. Canagliflozin was generally well tolerated with a similar overall incidence of adverse events between treatment groups. The rate of serious adverse events was 6.4% for canagliflozin vs. 5.6% for Januvia. Adverse events related to genital mycotic infections and to an osmotic diuresis were more frequent in patients treated with canagliflozin compared to Januvia. Data were presented at the American Diabetes Association meeting in Philadelphia. ...