PRINCETON, N.J. & WILMINGTON, Del.--(BUSINESS WIRE)--Findings from a 24-week Phase 3 clinical study published online in the latest issue of Diabetes Care demonstrated that the investigational drug dapagliflozin, administered as a monotherapy, achieved statistically significant mean reductions at 5 mg and 10 mg doses once daily in the primary endpoint of glycosylated hemoglobin levels (HbA1c) in treatment-naïve adult patients with newly diagnosed type 2 diabetes, compared to placebo. The study also showed reductions in the secondary endpoint of fasting plasma glucose (FPG) and total body weight compared to placebo in these patients. Signs, symptoms and other reports suggestive of urinary tract infections (UTIs) and genital infection were more frequently noted in the dapagliflozin arms and rarely led to treatment discontinuation. No major episodes of hypoglycemia were reported in the study. This data appears in a pre-print version of the study that is scheduled to be published in the September issue of Diabetes Care and is currently available online at http://diabetes.org/diabetescare. An abstract of this study was presented at the World Diabetes Congress in 2009.
