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Efficacy and Safety of Pioglitazone Versus Metformin in Patients with Type 2 Diabetes Mellitus: A Double-Blind, Randomized Trial

Department of Medicine I, Rudolfstiftung Hospital (G.S.), A-1030 Vienna, Austria; Oxford Center for Diabetes, Endocrinology, and Metabolism, Radcliffe Infirmary (D.R.M.), Oxford, OX2 6HE, United Kingdom; Clinique d’Endocrinologie, Hotel Dieu (B.C.), 44093 Nantes, France; Center for Clinical Studies, Gesellschaft für Wissens- und Technologietransfer, Technical University Dresden (M.H.), Dresden D-01307, Germany; and Internal Medicine and Metabolic Diseases Department, Universita di Perugia (P.B.), 06126 Perugia, Italy

Address all correspondence and requests for reprints to: Dr. G. Schernthaner, Department of Medicine I, Rudolfstiftung Hospital, Juchgasse 25, A-1030 Vienna, Austria. E-mail: guntram.schernthaner{at}wienkav.at.

Pioglitazone increases the insulin sensitivity of peripheral tissues and may provide an alternative first-line treatment for type 2 diabetes. This study compared metabolic control in drug-naive type 2 diabetes patients given either pioglitazone or metformin. Eleven hundred and ninety-nine patients with poorly controlled type 2 diabetes mellitus [glycosylated hemoglobin (HbA_1c), 7.5–11%; normal, 4.3–6.1%] were randomized to receive either pioglitazone (45 mg/d) or metformin (850 mg, three times daily). HbA_1c, fasting plasma glucose (FPG), insulin levels, total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol, triglycerides, free fatty acids, and urinary albumin/creatinine ratio were measured. Mean HbA_1c decreased in both treatment groups from baseline to wk 52 (–1.4% and –1.5%). Significantly greater mean reductions in FPG were observed in the pioglitazone group (–45.0 mg/dl; –2.5 mmol/liter) than in the metformin (–39.6 mg/dl; –2.2 mmol/liter) group (P = 0.016). Favorable changes in triglycerides and HDL-C were more pronounced with pioglitazone. Although low density lipoprotein cholesterol and TC levels increased with pioglitazone, TC/HDL-C ratios decreased similarly with both treatments. The urinary albumin/creatinine ratio was reduced by 19% with pioglitazone treatment, but remained unchanged with metformin therapy (–1%; P = 0.002). There was an increase in body weight of 1.9 kg in the pioglitazone group and a decrease of 2.5 kg in the metformin group. The overall frequency of adverse events was similar between treatment groups, but adverse event profiles were different between treatment groups. HbA_1c reduction is similar after pioglitazone and metformin monotherapies, but differences in FPG, plasma lipids, and adverse effects between the two compounds may influence decision-making in individual prescribers.

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Comparing Two Medications for Type 2 Diabetes

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