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A Placebo‐Controlled, Randomized Study of Glimepiride in Patients with Type 2 Diabetes Mellitus for Whom Diet Therapy is Unsuccessful
Author(s) -
Schade David S.,
Jovanovic Lois,
Schneider Jill
Publication year - 1998
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1998.tb04471.x
Subject(s) - glimepiride , medicine , postprandial , placebo , glycemic , hypoglycemia , type 2 diabetes , sulfonylurea , diabetes mellitus , insulin , adverse effect , gastroenterology , randomized controlled trial , endocrinology , alternative medicine , pathology
This multicenter, randomized, placebo‐controlled study of glimepiride, a new oral sulfonylurea, was conducted in patients with type 2 diabetes for whom dietary treatment was unsuccessful (fasting plasma glucose [FPG] = 151–300 mg/dL) during a 1‐week screening period. Patients were randomized to receive glimepiride (n = 123) or placebo (n = 126) once daily for a 10‐week dose‐titration period, then maintained on an individually 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 than placebo. Glimepiride improved postprandial insulin and C‐peptide responses without producing clinically meaningful increases in fasting insulin or C‐peptide levels. Good glycemic control (HbA 1 ≤ 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 laboratory 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.