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The Journal of Clinical Endocrinology & Metabolism Vol. 86, No. 1 280-288
Copyright © 2001 by The Endocrine Society

Original Studies

Rosiglitazone Monotherapy Is Effective in Patients with Type 2 Diabetes

Harold E. Lebovitz, Jo F. Dole, Rita Patwardhan, Elizabeth B. Rappaport, Martin I. Freed and for the Rosiglitazone Clinical Trials Study Group1

Department of Medicine, State University of New York (H.E.L.), Brooklyn, New York 11203; and SmithKline Beecham Pharmaceuticals (J.F.D., R.P., E.B.R., M.I.F.), Collegeville, Pennsylvania

Address all correspondence and requests for reprints to: Harold E. Lebovitz, M.D., Department of Medicine, Division of Endocrinology, State University of New York Health Science Center, 450 Clarkson Avenue, Box 50, Brooklyn, New York 11203. E-mail: hlebovitz{at}attglobal.net

This study evaluated the efficacy and safety of rosiglitazone monotherapy in patients with type 2 diabetes. After a 4-week placebo run-in period, 493 patients with type 2 diabetes were randomized to receive rosiglitazone [2 or 4 mg twice daily (bd)] or placebo for 26 weeks. The primary end point was change in hemoglobin A1c; other variables assessed included fasting plasma glucose, fructosamine, endogenous insulin secretion, urinary albumin excretion, serum lipids, and adverse events. Rosiglitazone (2 and 4 mg bd) decreased mean hemoglobin A1c relative to placebo by 1.2 and 1.5 percentage points, respectively, and reduced fasting plasma glucose concentrations relative to placebo by 3.22 and 4.22 mmol/L, respectively. Fasting plasma insulin and insulin precursor molecules decreased significantly. Homeostasis model assessment estimates indicate that rosiglitazone (2 and 4 mg bd) reduced insulin resistance by 16.0% and 24.6%, respectively, and improved ß-cell function over baseline by 49.5% and 60.0%, respectively. Urinary albumin excretion decreased significantly in the rosiglitazone (4 mg bd) group. There was no increase in adverse events with rosiglitazone. In the short-term, rosiglitazone is an insulin sensitizer that is effective and safe as monotherapy in patients with type 2 diabetes who are inadequately controlled by lifestyle interventions.




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