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Issue 108 Item 7 AACE: Combination Therapy Best For Diabetics With Higher Glycem

Apr 23, 2002

First line treatment of glyburide and metformin found to be safe and effective with synergistic results. A combination of glyburide and metformin are effective and safe as first-line therapy in patients with inadequately controlled type 2 diabetes, researchers reported here today at the annual meeting of the American Association of Clinical Endocrinologists.

Also, combination treatment with glyburide/metformin (G/M) 1.25/250 mg demonstrated clinical usefulness in patients with poor baseline control, the researchers said.

For the 16-week, double-blind, researchers led by A. J. Garber, MD, professor of medicine at Baylor University College of Medicine, in Houston, Texas, enrolled 486 drug naive subjects, 20 to 78 years of age, with body mass index in the range of 23-40 kg/m².

Patients were randomized to receive glyburide 2.5 mg, metformin 500 mg, or G/M 1.25/250 mg. Investigators titrated doses for patients with mean daily glucose 126 mg/dL or higher.

Primary end point was change in hemoglobin A1c (HbA1c) values at week 16.

Mean final doses were: 7.6 mg for glyburide monotherapy, 1796 mg for metformin monotherapy, and 3.7/735 mg for G/M.

G/M reduced HbA1c from baseline by 2.3 percent compared to reductions of 1.9 percent with glyburide and 1.5 percent with metformin (p=0.0003 for superiority of G/M over monotherapy). For patients with HbA1c levels of 12 percent or higher, G/M resulted in better glycemic control than the use of either agent as a monotherapy.

The authors noted that, in a previous trial, G/M showed superior glycemic control when compared to glyburide and metformin monotherapy. However, they said, "This study is unique because it includes patients with higher baseline HbA1c values."
(The study was sponsored by Bristol-Myers Squibb.)