The Synergistic Effect of Miglitol Plus Metformin Combination Therapy in the Treatment of Type 2 Diabetes

The Synergistic Effect of Miglitol Plus Metformin Combination Therapy in the Treatment of Type 2 Diabetes Jean-Louis Chiasson , MD 1 , Lisa Naditch , MD 2 and for the Miglitol Canadian University Investigator Group 1 Research Group on Diabetes and Metabolic Regulation, Research Center, Centre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada 2 Sanofi-Synthelabo, Paris, France Abstract OBJECTIVE —To investigate the efficacy and safety of miglitol in combination 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-controlled study, 324 patients with type 2 diabetes were randomized, after an 8-week placebo run-in period, to treatment with either placebo, miglitol alone, metformin alone, or miglitol plus metformin for 36 weeks. The miglitol was titrated to 100 mg three times a day and metformin was administered at 500 mg three times a day. The primary efficacy criterion was change in HbA 1c from baseline to the end of treatment. Secondary parameters included changes in fasting and postprandial plasma glucose and insulin levels, serum 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 different from treatment with metformin alone (−1.25; P = 0.002). Miglitol plus metformin 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 postprandial glucose area under the curve (−59.0 vs. –18.0 mg/dl; P = 0.0001), and responder rate (70.6 vs. 45.52%; P = 0.0014). All therapies were well tolerated. CONCLUSIONS —In type 2 diabetic patients, miglitol in combination with metformin gives greater glycemic improvement than metformin monotherapy. AUC, area under the curve ITT, intent to treat Footnotes Address correspondence and reprint requests to Jean-Louis Chiasson, MD, Research Group on Diabetes and Metabolic Regulation, Research Center CHUM, Hôtel-Dieu CHUM, 3850 St. Urbain, 8–202, Montreal, Quebec, Canada H2W 1T8. E-mail: jean.louis.chiasson{at}umontreal.ca . Received for publication 28 November 2000 and accepted in revised form 6 February 2001. L.N. is an employee of Sanofi-Synthelabo, which is involved in the marketing of the product