ARTICLE | Clinical News

Dapagliflozin: Additional Phase III data

July 11, 2011 7:00 AM UTC

Data from 339 Type II diabetics inadequately controlled with metformin in the 78-week extension of a 24-week, double-blind Phase III trial showed that 2.5, 5 and 10 mg once-daily dapagliflozin plus metformin reduced HbA1c by 0.48%, 0.58% and 0.78%, respectively, from baseline to week 102 vs. a gain of 0.02% for placebo plus metformin. Low-, mid- and high-dose dapagliflozin plus metformin also led to greater reductions in mean FPG (19.3, 24.5 and 26.4 mg/dL, respectively, vs. 10.4 mg/dL) and body weight vs. placebo plus metformin at week 102 (1.1, 1.7 and 1.74 kg, respectively, vs. a gain of 1.36 kg). Data were presented at the American Diabetes Association meeting in San Diego. ...