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This study evaluated the efficacy and safety of 26 weeks of twice‐daily ( BID ) alogliptin + metformin fixed‐dose combination ( FDC ) therapy in Asian patients with type 2 diabetes. Patients aged 18 to 75 years with hemoglobin  A 1c ( HbA1c ) of 7.5% to 10.0% after ≥2 months of diet and exercise and a 4‐week placebo run‐in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, alogliptin 12.5 mg  BID , metformin 500 mg  BID  or alogliptin 12.5 mg plus metformin 500 mg  FDC BID . The primary endpoint was change in  HbA1c  from baseline to end of treatment ( W eek 26). In total, 647 patients were randomized. The least‐squares mean change in  HbA1c  from baseline to  W eek 26 was −0.19% with placebo, −0.86% with alogliptin, −1.04% with metformin and −1.53% with alogliptin + metformin  FDC . Alogliptin + metformin  FDC  was significantly more effective (  P   < .0001) in lowering  HbA1c  than either alogliptin or metformin alone. The safety profile of alogliptin + metformin  FDC  was similar to that of the individual components alogliptin and metformin. The study demonstrated that treatment with alogliptin + metformin  FDC BID  resulted in better glycaemic control than either monotherapy and was well tolerated in Asian patients with type 2 diabetes.

Efficacy and safety of fixed‐dose combination therapy, alogliptin plus metformin, in A sian patients with type 2 diabetes: A phase 3 trial