Dapagliflozin as monotherapy demonstrates potential for type 2 diabetes treatment

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.

“These findings of dapagliflozin as a monotherapy, together with an additional Phase 3 study of dapagliflozin in combination with metformin which was presented at the 2009 European Association for the Study of Diabetes annual meeting, show the potential of this agent to help patients with type 2 diabetes”

Dapagliflozin, an investigational compound, is a potential first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor currently in Phase 3 trials under joint development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (LSN, NYSE: AZN) as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes. SGLT2 inhibitors facilitate the elimination of glucose by the kidney, which should result in lowering serum glucose levels.

"These findings of dapagliflozin as a monotherapy, together with an additional Phase 3 study of dapagliflozin in combination with metformin which was presented at the 2009 European Association for the Study of Diabetes annual meeting, show the potential of this agent to help patients with type 2 diabetes," said Ele Ferrannini, MD, Professor of Internal Medicine, Department of Internal Medicine, University of Pisa School of Medicine (Italy).

SOURCE AstraZeneca