Efficacy and Safety of Glimepiride: A Novel Sulfonylurea Drug Compared with Gliclazide in the Treatment of Type 2 Diabetes Mellitus: an Open, Randomized Comparative Multi-Center Clinical Study

Background: Glimepiride (HOE490, AmarylR) is a new, third generation sulfonylurea, which binds to a different protein of the sulfonylurea receptor than other sulfonylureas. Although there have been many studies proving the efficacy of glimepiride on Caucasian diabetic patients, only a few studies are assailable on Asian diabetic patients. We performed an open, randomized, comparative multicenter clinical trial to assess the efficacy and safety of glimepiride in Korean type 2 diabetic patients. Method: We recruited 262 type 2 diabetic patients at 12 different university hospitals whose blood glucose was not controlled effectively with diet alone. Patients were randomized to 1∼2 ㎎ glirnepiride or 40∼80 ㎎ gliclazide depending on the fasting blood glucose level. Doses were increased stepwise, up to 8 ㎎ for glimepiride (once-daily) and 320 ㎎ for gliclazide (>80 ㎎ as divided dose) respectively, until metabolic control (fasting blood glucose