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This randomized, double‐blind, phase  III  study evaluated the efficacy and safety of once‐daily treatment with alogliptin (25 mg once daily), alone or with metformin hydrochloride (500 mg once daily or 250 mg twice daily), in Japanese patients with type 2 diabetes. The primary endpoint was change in glycated haemoglobin ( HbA1c ) from baseline to the end of treatment (week 24). The least squares ( LS ) mean (standard error) change in  HbA1c  from baseline to the end of treatment (week 24) was 0.16 (0.072)% in alogliptin alone, −0.49 (0.049)% in alogliptin/metformin once daily, and −0.60 (0.049)% in alogliptin/metformin twice daily. The  LS  mean difference in  HbA1c  change from baseline between alogliptin/metformin once daily and alogliptin alone (alogliptin/metformin once daily minus alogliptin alone) was −0.65% (95% confidence interval [ CI ] −0.821, −0.480) and between alogliptin/metformin once daily and twice daily (once daily minus twice daily) was 0.11% (95%  CI  −0.026, 0.247). The overall frequency of adverse events was similar among the groups. This study showed that the efficacy of alogliptin/metformin once daily was superior to alogliptin alone and non‐inferior to alogliptin/metformin twice daily, and that alogliptin/metformin once daily was safe and well tolerated in Japanese patients with type 2 diabetes.

diabetes, obesity and metabolism

Randomized, double‐blind, phase  III  study to evaluate the efficacy and safety of once‐daily treatment with alogliptin and metformin hydrochloride in Japanese patients with type 2 diabetes