Strong Ph III data on AstraZeneca/B-MS's dapagliflozin

Results from a 24-week Phase III clinical study demonstrated that the investigational drug dapagliflozin, added to metformin, demonstrated significant mean reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c) and in the secondary endpoint, fasting plasma glucose (FPG) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin.

Dapagliflozin is a novel, selective, sodium glucose co-transporter 2 (SGLT2) inhibitor, currently in Phase III trials under joint development by US drug major Bristol-Myers Squibb and Anglo-Swedish firm AstraZeneca. The study also showed that individuals receiving dapagliflozin had statistically greater mean reductions in body weight compared to individuals taking placebo. Results from the 24-week study were presented at the 45th European Association for the Study of Diabetes Annual Meeting. This is the first public presentation of dapagliflozin Phase III data.

Dapagliflozin, an investigational compound, is a potential first-in-class SGLT2 inhibitor currently in Phase III trials under joint development as a once-daily oral therapy for the treatment of type 2 diabetes. SGLT2 inhibitors facilitate the elimination of glucose by the kidney, thereby returning serum glucose levels towards normal.