Dapagliflozin: Phase III data

A double-blind, international Phase III trial in 597 patients with inadequately controlled Type II diabetes showed that all 3 doses of oral dapagliflozin as an add-on to glimepiride met the primary endpoint of significantly reducing HbA1c from baseline to week 24 vs. placebo plus glimepiride. Specifically, 2.5, 5 and 10 mg once-daily dapagliflozin plus glimepiride reduced HbA1c by 0.58%, 0.63% and 0.82%, respectively, vs. 0.13% for placebo plus glimepiride (p<0.0001 for all). Mid- and high-dose dapagliflozin plus glimepiride also met the secondary endpoints of significantly reducing mean body weight (1.56 and 2.26 kg, respectively, vs. 0.72 kg; p<0.01 and p<0.0001), OGTT (32 and 34.9 mg/dL, respectively, vs. 6 mg/dL; p<0.01 and p<0.0001), FPG (21.2 and 28.5 mg/dL, respectively, vs. 2 mg/dL; p<0.0001 for both), and of a significantly greater proportion of patients achieving an HbA1c <7% (30.3% and 31.7%, respectively, vs. 13%; p<0.01 and p<0.0001) at week 24 vs. placebo plus glimepiride. Low-dose dapagliflozin plus glimepiride reduced mean body weight by 1.18 kg, OGTT by 37.5 mg/dL, FPG by 16.8 mg/dL, and 26.8% of patients achieved an HbA1c <7%. ...