Results from a 24-week phase 3 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 3 trials under joint development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (LSE, NYSE: AZN). 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 3 data.
Dapagliflozin, an investigational compound, is a potential first-in-class SGLT2 inhibitor currently in Phase 3 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.
“Given the continued rising prevalence of type 2 diabetes, development of novel treatments such as SGLT2 inhibitors are needed to help improve glycemic control. The preliminary data on weight loss and blood pressure may be important adjuvants to glycemic control,” said Cliff Bailey, Professor of Clinical Science and Head of Diabetes Research at Aston University, Birmingham, UK. “We look forward to additional data from pivotal dapagliflozin studies which will explore the potential benefits of this new class of medicine for type 2 diabetes patients.”