Phase 3 trial of dapagliflozin plus metformin for type 2 diabetes

Bristol-Myers Squibb and Astra Zeneca announced positive results from a Phase 3 study of dapagliflozin in adults with type 2 diabetes inadequately controlled on metformin monotherapy. The 52-week, multicenter, randomized, parallel-group, double-blind, active-controlled trial assessed whether the change from baseline in HbA1c levels with dapagliflozin plus metformin was non-inferior to glipizide plus metformin in adult patients with type 2 diabetes who had inadequate glycemic control on metformin ≥1500mg/day alone.

Treatments were titrated during the first 18 weeks, up to 10mg/day for dapagliflozin plus metformin or 20mg/day for glipizide. The study demonstrated dapagliflozin to be non-inferior compared to glipizide in improving HbA1c levels when added to existing metformin therapy during a 52-week treatment period (difference in adjusted mean change from baseline vs. glipizide as added to existing metformin therapy was 0.00%, 95% CI -0.11 to 0.11). The study also demonstrated that dapagliflozin plus metformin achieved significant reductions in key secondary endpoints: reduction in total body weight from baseline, compared with a weight gain on glipizide plus metformin therapy metformin (-3.22kg vs. +1.44kg, respectively; p<0.0001), and a reduced number of patients reporting one or more hypoglycemic events.

Dapagliflozin is an investigational first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor. The renal SGLT system plays a major role in overall glucose balance in the body. Normally, the kidney filters about 180g of glucose per day, and virtually all is reabsorbed back into circulation. Glucose reabsorption occurs in the proximal tubule of the kidney via the SGLT system. Selective inhibition of SGLT2 by an insulin independent mechanism of action facilitates the excretion of glucose and associated calories in the urine, thereby lowering blood glucose levels.

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