AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase III study evaluating dapagliflozin 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 49 th 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 hypoglycemia, genital infection and renal adverse events compared to the placebo group. Rates of urinary tract infection were the same for both groups.
“The improvements in glycemic control combined with the significant reduction in body weight observed in this study add to the clinical profile of dapagliflozin, specifically when used as part of a triple oral therapy regimen with metformin and sulfonylurea,” said Stephan Matthaei, M.D., primary study investigator and director of the Diabetes and Metabolism Center, Quakenbrück Hospital, Quakenbrück, Germany.
Dapagliflozin is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin. It is currently approved for the treatment of type 2 diabetes in the European Union, Australia, Brazil, Mexico and New Zealand. A resubmission of the New Drug Application (NDA) for dapagliflozin was accepted for review by the U.S. Food and Drug Administration (FDA) in July 2013 with a new Prescription Drug User Fee Act (PDUFA) goal date of January 11, 2014.