The synergistic effect of miglitol plus metformin combination therapy in the treatment of type 2 diabetes

OBJECTIVE - To investigate the efficacy and safety of miglitol in combinati on with metformin in improving glycemic control in outpatients in whom type 2 diabetes is insufficiently controlled by diet alone. RESEARCH DESIGN AND METHODS - In this multicenter, double-blind, placebo co ntrolled study, 324 patients with type 2 diabetes were randomized, after an 8-week placebo run-in period, to treatment with either placebo, miglitol a lone, metformin alone, or miglitol plus metformin for 36 weeks. The miglito l was titrated to 100 mg three times a day and metformin was administered a t 500 mg three times a day. The primary efficacy criterion was change in Hb A(1c) from baseline to the end of treatment. Secondary parameters included changes in fasting and postprandial plasma glucose and insulin levels, seru m triglyceride levels, and responder rate. RESULTS - A total of 318 patients were valid for intent-to-treat analysis. A reduction in mean placebo-subtracted HbA(1c) of -1.78% was observed with miglitol plus metformin combination therapy, which was significantly differ ent from treatment with metformin alone (-1.25; P = 0.002). Miglitol plus m etformin also resulted in better metabolic control than metformin alone for Fasting plasma glucose (-44.8 vs. -20.4 mg/dl; P = 0.0025), 2-h postprandi al glucose area under the curve (-59.0 vs. -18.0 mg/dl; P 0.0001), and resp onder rare (70.6 vs. 45.52%; P = 0.0014). All therapies were well tolerated . CONCLUSIONS - In type 2 diabetic patients, miglitol in combination with met formin gives greater glycemic improvement than metformin monotherapy.