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Diabetes Care 25:2133-2140, 2002
© 2002 by the American Diabetes Association, Inc.

Clinical Care/Education/Nutrition
Original Article

Combination of Insulin and Metformin in the Treatment of Type 2 Diabetes

Michiel G. Wulffelé, MD1, Adriaan Kooy, MD, PHD1, Philippe Lehert, PHD2, Daniel Bets, MSC3, Jeles C. Ogterop, MD4, Bob Borger van der Burg, MD5, Ab J.M. Donker, MD, PHD6 and Coen D.A. Stehouwer, MD, PHD6

1 Department of Internal Medicine, Bethesda Hospital Hoogeveen, Drenthe, the Netherlands
2 Department of Biostatistics, University of Mons, Mons, Belgium
3 Clinical Research and Development, E. Merck Nederland B.V. Amsterdam, Noord Holland, the Netherlands
4 Department of Internal Medicine, Deaconesses’ Hospital Meppel, Drenthe, the Netherlands
5 Department of Internal Medicine, Aleida Kramer Hospital Coevorden, Drenthe, the Netherlands
6 Department of Internal Medicine and Institute for Cardiovascular Research, Vrije Universiteit Medical Centre, Amsterdam, Noord Holland, the Netherlands

OBJECTIVE—To investigate the metabolic effects of metformin, as compared with placebo, in type 2 diabetic patients intensively treated with insulin.

RESEARCH DESIGN AND METHODS—Metformin improves glycemic control in poorly controlled type 2 diabetic patients. Its effect in type 2 diabetic patients who are intensively treated with insulin has not been studied. A total of 390 patients whose type 2 diabetes was controlled with insulin therapy completed a randomized controlled double-blind trial with a planned interim analysis after 16 weeks of treatment.The subjects were selected from three outpatient clinics in regional hospitals and were randomly assigned to either the placebo or metformin group, in addition to insulin therapy. Intensive glucose monitoring with immediate insulin adjustments according to strict guidelines was conducted. Indexes of glycemic control, insulin requirements, body weight, blood pressure, plasma lipids, hypoglycemic events, and other adverse events were measured.

RESULTS—Of the 390 subjects, 37 dropped out (12 in the placebo and 25 in the metformin group). Of those who completed 16 weeks of treatment, metformin use, as compared with placebo, was associated with improved glycemic control (mean daily glucose at 16 weeks 7.8 vs. 8.8 mmol/l, P = 0.006; mean GHb 6.9 vs. 7.6%, P < 0.0001); reduced insulin requirements (63.8 vs. 71.3 IU, P < 0.0001); reduced weight gain (-0.4 vs. +1.2 kg, P < 0.01); and decreased plasma LDL cholesterol (-0.21 vs. -0.02 mmol/l, P < 0.01). Risk of hypoglycemia was similar in both groups.

CONCLUSIONS—In type 2 diabetic patients who are intensively treated with insulin, the combination of insulin and metformin results in superior glycemic control compared with insulin therapy alone, while insulin requirements and weight gain are less.

Abbreviations: HOME, Hyperinsulinemia: the Outcome of its Metabolic Effects • UKPDS, U.K. Prospective Diabetes Study


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