제2형 당뇨병 환자 치료에 있어서 GLIMEPIRIDE와 GLICLAZIDE의 유효성 및 안전성 비교,평가를 위한 다기관 공동 제3상 임상시험

Abstract

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<7.9 mmol/L) or maximum dose was achieved. The quality of metabolic control was assessed by fasting blood glucose and HbA1c primary variables. Insulin, C-peptide and weight were monitored as secondary variables. Safety was assessed by obtaining patient history and laboratory values of relevant variables. Results: Of the 262 patients randomized to treatment, 160 (61%) patients completed the 18-week study The rate of successful blood glucose control(3.9not statistically different. The changes of secondary parameters, such as fasting blood glucose, postprandial 2h glucose, HbAlc, fasting serum insulin, fasting serum C-peptide were not significantly different between the two groups. The side effects of the two drugs including hypoglycemia frequency, biochemical laboratory variables were also not different between the groups. Conclusion: The efficacy and safety of glimepiride was equivalent to gliclazide for the Korean type 2 diabetic patients. Glimepiride can be used effectively and safely for the control of hypeiglycemia in diabetic patients. As glimepiride was equally effective with single dose, it was expected that this drug may improve patients' compliance.