Invokana canagliflozin: Phase III data

The double-blind, placebo-controlled, international Phase III CANTATA-D (DIA3006) trial in 1,284 Type II diabetics with inadequate glycemic control on maximally effective doses of metformin showed that once-daily 300 mg canagliflozin significantly reduced HbA1c from baseline to week 52 vs. Januvia sitagliptin (0.88% vs. 0.73%). The once-daily 100 mg dose of canagliflozin was non-inferior to Januvia on the endpoint (0.73%). Additionally, both doses of canagliflozin led to significantly greater reductions in FPG (26.2 and 35.2 mg/dL, respectively, vs. 17.7 mg/dL, p<0.001 for both), body weight (3.8% and 4.2%, respectively, vs. 1.3%, p<0.001 for both) and SBP (3.5 and 4.7 mmHg, respectively, vs. 0.7 mmHg, p<0.001 for both) vs. Januvia.

Additionally, 41.4% of patients receiving low-dose canagliflozin and 54.7% of patients receiving high-dose canagliflozin achieved an HbA1c of <7% at week 52 vs. 50.6% for Januvia. Low-dose canagliflozin increased HDL-C by 11.2% and LDL-C by 7.7% from baseline to week 52; high-dose canagliflozin increased HDL-C by 13.3% and LDL-C by 8.7%; and Januvia increased each endpoint by 6%, respectively. Patients received once-daily 100 or 300 mg canagliflozin, Januvia or placebo for 26 weeks followed by Januvia for 26 weeks. Data were presented at the American Diabetes Association meeting in Chicago. ...