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Positive Phase III Results Reported for Dapagliflozin in Patients With Type 2 Diabetes
FDA review slated for January 2014 (September 24)
Positive results have been reported from a phase III study evaluating dapagliflozin (AstraZeneca/Bristol-Myers Squibb) 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 (HbA1c) levels and, among key secondary endpoints, significant reductions in fasting plasma glucose (FPG) and in body weight compared with placebo at 24 weeks. Significant improvements were also observed in seated systolic blood pressure (SBP) at 8 weeks in patients treated with dapagliflozin compared with placebo.
The results were presented Sept. 24 at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.
In the study, overall rates of adverse events were similar between the two treatment groups, and most events were reported as mild or moderate in intensity. More patients in the dapagliflozin group reported hypoglycemia, genital infection, and renal adverse events compared with the placebo group. Rates of urinary-tract infection were the same for both groups.
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 FDA in July 2013, with a new Prescription Drug User Fee Act (PDUFA) goal date of January 11, 2014.
Source: AstraZeneca; September 24, 2013.