On September 24 2010 Bristol-Myers Squibb Company and AstraZeneca announced positive results from a randomized, double-blind Phase 3 clinical study for their collaborative drug dapagliflozin aimed at treating adults with type 2 diabetes. The two companies entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.
The Phase 3 study demonstrated dapagliflozin was non-inferior compared to glipizide (sulphonylurea) in improving glycosylated hemoglobin levels (HbA1c) when added to existing metformin therapy during a 52-week treatment period. The study also demonstrated that dapagliflozin plus metformin achieved significant reductions in key efficacy secondary endpoints: reduction in total body weight from baseline, compared with a weight gain on glipizide plus metformin therapy and a reduced number of patients reporting one or more hypoglycemic events. Overall, the frequencies of adverse events, serious adverse events and study discontinuations were comparable across the two treatment groups; although signs, symptoms and other reports suggestive of urinary tract or genital infections were more common in dapagliflozin treated subjects.
Dapagliflozin, an investigational compound, is a first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor and is currently in Phase 3 trials under joint development by Bristol-Myers Squibb and AstraZeneca as a once-daily oral therapy for the treatment of adult patients with type 2 diabetes. SGLT2 inhibitors, which act independently of insulin mechanisms, facilitate the excretion of glucose and associated calories in the urine, thereby lowering blood glucose levels.