AstraZeneca/Bristol-Myers dapagliflozin shows positive results in Ph III trial

Positive results from a randomized, double-blind Phase III clinical study of Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca’s (LSE: AZN) dapagliflozin in adults with type 2 diabetes inadequately controlled on metformin therapy alone were presented last week at the 46th European Association for the Study of Diabetes (EASD) annual meeting held in Stockholm, Sweden.

The study demonstrated that 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. Treatments were titrated during the first 18 weeks, up to 10mg/day for dapagliflozin plus metformin (median dose 10mg/day) or 20mg/day for glipizide (median dose 20mg/day).

Given that the drug gets regulatory approval, dapagliflozin would be the first diabetes drug of its kind on the market. Unlike traditional diabetes drugs, it is an SGLT2 inhibitor, which blocks glucose from being reabsorbed. Another SGLT2 drug, Johnson & Johnson’s canagliflozin, is also currently in Phase III development.