Phase III success for dapagliflozin in Type 2 Diabetes

AstraZeneca and BMS announced results from a Phase III study evaluating dapagliflozin (Forxiga in EU) in adult patients with Type 2 Diabetes who were inadequately controlled on combination treatment with metformin plus sulfonylurea. Patients treated with dapagliflozin 10 mg as an add-on therapy to metformin plus sulfonylurea demonstrated significant improvements in glycosylated hemoglobin levels (HbA1c) and, among key secondary endpoints, significant reductions in fasting plasma glucose (FPG) and in body weight compared to placebo at 24 weeks. Significant improvements were also observed in seated systolic blood pressure (SBP) at eight weeks in patients treated with dapagliflozin compared to placebo. The results were presented today at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.

In this study, overall rates of adverse events were similar between the two treatment groups, and most were reported as mild or moderate in intensity. More patients in the dapagliflozin group reported hypoglycaemia, genital infection and renal adverse events compared to the placebo group.