TUESDAY, April 17 (HealthDay News) -- The sulfonylurea glimepiride is a safe and effective monotherapy for pediatric type 2 diabetes, according to a randomized, single-blind study comparing the drug to metformin. The findings are published in the April issue of Diabetes Care.
Michael Gottschalk, M.D., from the University of California, San Diego, Medical Center and colleagues, randomized 285 multinational patients to receive 1 to 8 mg of glimepiride once daily or 500 to 1,000 mg metformin twice daily for 26 weeks. Metformin is currently the only oral antihyperglycemic agent specifically approved for pediatric use by the U.S. Food and Drug Administration.
Both treatment groups showed significant reductions in hemoglobin A1C at week 24 with 42.4 percent of subjects in the glimepiride group and 48.1 percent of the metformin group achieving A1C of less than 7.0 percent. Each group had less than 5 percent hypoglycemic episodes and one hypoglycemic event. The glimepiride group also showed greater weight gain.
"The results of this study indicate that glimepiride is safe and effective
for use in the pediatric population over 24 weeks and provide a needed addition to what is known about the use of antihyperglycemic agents in this population," the authors wrote.
The trial was supported by Sanofi-Aventis, and some of the authors are employed by the company or have received compensation from Sanofi-Aventis or other pharmaceutical companies.
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