A PLACEBO-CONTROLLED, RANDOMIZED STUDY OF GLIMEPIRIDE IN PATIENTS WITH TYPE-2 DIABETES-MELLITUS FOR WHOM DIET THERAPY IS UNSUCCESSFUL

This multicenter, randomized, placebo-controlled study of glimepiride, a new oral sulfonylurea, was conducted in patients with type 2 diabet es for whom dietary treatment was unsuccessful (fasting plasma glucose [FPG] = 151-300 mg/dL) during a 1-week screening period. Patients rr ere randomized to receive glimepiride (n = 123) or placebo (n = 126) o nce daily for a 10-week dose-titration period, then maintained on an i ndividually determined optimal dose (1-8 mg of glimepiride or placebo) for 12 weeks. Glimepiride lowered FPG by 46 mg/dL, hemoglobin A(1C) ( HbA(1C)) by 1.4%, and 2-hour postprandial glucose by 72 mg/dL more tha n placebo. Glimepiride improved postprandial insulin and C-peptide res ponses without producing clinically meaningful increases in fasting in sulin or C-peptide levels. Good glycemic control (HbA(1C) less than or equal to 7.2%) was achieved by 69% of the patients taking glimepiride versus 32% of those taking placebo. The overall incidence of adverse events was similar in both groups. No clinically noteworthy abnormal l aboratory values or hypoglycemia (blood glucose < 60 mg/dL) occurred. Glimepiride is safe and effective for treatment of patients with type 2 diabetes for whom diet therapy is unsuccessful. Journal of Clinical Pharmacology, 1998;38:636-641 (C)1998 The American College of Clinical Pharmacology.