Phase 3 Trial of Dapagliflozin in Combination with Glimepiride for Type 2 Diabetes
Bristol-Myers Squibb and AstraZeneca announced results from a Phase 3 clinical study which showed that reductions in HbA1c seen at 24 weeks with dapagliflozin added to existing (glimepiride) therapy were maintained at 48 weeks in 592 adults with type 2 diabetes. In addition, the 48-week study reported that patients taking dapagliflozin added to glimepiride maintained reductions in fasting plasma glucose levels, post-prandial glucose, and total body weight. These results are from a 24-week, multicenter, randomized, parallel-group, double-blind, placebo-controlled study with a 24-week extension.
Dapagliflozin, an inhibitor of SGLT2, a target in the kidney, is being investigated to evaluate its safety and efficacy in improving glycemic control in adults with type 2 diabetes, as an adjunct to diet and exercise, for use as a monotherapy and in combination with other anti-diabetic agents.