Dapagliflozin: Phase III data

A double-blind Phase III trial in 814 patients with Type II diabetes inadequately controlled with metformin showed that dapagliflozin plus metformin met the primary endpoint of non-inferiority to glipizide plus metformin in change from baseline in HbA1c at week 52 (0.52% for both). Dapagliflozin plus metformin also met the secondary endpoint of significantly reducing weight loss from baseline to week 52 vs. glipizide plus metformin (3.22 kg reduction vs. 1.44 kg increase, p<0.0001). Furthermore, a significantly greater proportion of patients receiving dapagliflozin plus metformin achieved >=5% body weight loss vs. glipizide plus metformin (33.3% vs. 2.5%, p<0.0001). Dapagliflozin plus metformin also reduced systolic and diastolic blood pressure by 4.3 and 1.6 mmHg, respectively, vs. an increase of 0.8 mmHg and a reduction of 0.4 mmHg in systolic and diastolic blood pressure, respectively, for glipizide plus metformin. ...