Efficacy and tolerability of sustained–release metformin in combination with gliquidone or acarbose for the treatment of type 2 diabetes mellitus: a multicentre, randomized, open–labeled and parallel–group study

Abstract

Objective To understand the efficacy and safety of sufficient dose of metformin either plus gliquidone or plus acarbose for the treatment of type 2 diabetes mellitus. Method One hundred and forty patients with type 2 diabetes who were inadequately controlled with previous therapy were randomized to receive sustained–release metformin(1500 mg/d) in combination with either gliquidone(start with 30 mg, bid) or acarbose(start with 50 mg, bid) for 14 weeks. The anthropometric parameters, fasting blood glucose levels, lipid profiles, HbA1c and post–challenge glucose and insulin responses were measured at baseline and at the end of treatment. Results After 14 weeks treatment, the level of the glycated hemoglobin A1c (HbA1c) in the 2 group were both decreased than before(metformin+ gliquidone group with (7.4±1.1)%, metformin+ acarbose group with (7.8±1.1)%). The level of HbA1c decreased significantly more in metformin plus gliquidone group(1.7%) than in metformin plus acarbose group(0.9%), P=0.0001. The rate of HbA1c<6.5% was 25.71% in metformin plus gliquidone group, compared to 12.86% in metformin plus acarbose group(P=0.054). The insulin resistance index(HOMA–IR) and the beta–cell function index (HOMA–β) improved significantly in both groups, but no difference was observed between the two groups. Conclusion As compared to metformin plus acarbose, the combined therapy with metformin plus gliquidone more significantly improved glycemic control and was well tolerated among inadequately controlled patients with type 2 diabetes. Key words: Type 2 diabetes mellitus; Gliquidone; Acarbose