摘要
Aim: To compare the efficacy and safety of acarbose plus metformin fixed-dose combination (FDC) versus acarbose monotherapy for type 2 diabetes (T2D). Methods: Eligible T2D patients undergoing treatment with diet control only or oral antidiabetic medications were run-in on acarbose 50. mg thrice-daily for 4 weeks, then randomised either to continue this monotherapy, or to acarbose 50. mg plus metformin hydrochloride 500. mg FDC (acarbose/metformin FDC), each thrice-daily for 16 weeks. Results: Acarbose/metformin FDC therapy significantly reduced HbA1c, fasting plasma glucose (FPG), and postprandial plasma glucose (PPG) from baseline (all p<. 0.0001) with superior efficacy compared with acarbose monotherapy (between-group differences; HbA1c -1.35%; FPG -29.5. mg/dl; PPG -41.6. mg/dl; all p<. 0.0001). Proportionally more patients treated with acarbose/metformin FDC achieved HbA1c <7.0% (47.8% vs. 10.7%, p<. 0.0001). Both treatments reduced bodyweight (p<0.0001), with a significant between-group difference (-0.6. kg, p<0.01) favouring acarbose/metformin FDC. Hypoglycaemia was not reported with either treatment, and the incidence of other adverse events did not differ significantly between the groups. Conclusions: Compared with acarbose monotherapy, acarbose/metformin FDC has superior antihyperglycaemic efficacy, brings proportionally more T2D patients to HbA1c goal, and further reduces bodyweight. Acarbose/metformin FDC is well-tolerated without significant risk of hypoglycaemia and is a potentially advantageous therapy for T2D. © 2013 Elsevier Ireland Ltd.