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Efficacy and safety of fixed‐dose combination therapy, alogliptin plus metformin, in A sian patients with type 2 diabetes: A phase 3 trial
Author(s) -
Ji Lig,
Li Ling,
Kuang Jian,
Yang Tao,
Kim DongJun,
Kadir Azidah A.,
Huang ChienNing,
Lee Douglas
Publication year - 2017
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12875
Subject(s) - alogliptin , metformin , type 2 diabetes , placebo , medicine , pharmacology , clinical endpoint , diabetes mellitus , fixed dose combination , randomized controlled trial , endocrinology , alternative medicine , pathology , sitagliptin
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.