J Korean Diabetes Assoc.
1999 Feb;23(1):87-97.
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
- Affiliations
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- 1Department of Internal Medicine, College of Medicine, Ulsan University.
- 2Department of Internal Medicine, College of Medicine, Chung-Ang University.
- 3Department of Internal Medicine, College of Medicine, Catholic University.
- 4Department of Internal Medicine, College of Medicine, Sungkyunkwan University.
- 5Department of Internal Medicine, College of Medicine, Yonsei University.
- 6Department of Internal Medicine, College of Medicine, Korea University.
- 7Department of Internal Medicine, College of Medicine, Kyung Hee University.
- 8Department of Internal Medicine, College of Medicine, Ajou University.
- 9Department of Internal Medicine, College of Medicine, Seoul National University.
Abstract
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BACKGROUND: Glimepiride (HOE490, Amaryl (R)) 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 available 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 cliabetic patients at 12 different university hospitals whose blood glucose was not controlled effectively with diet alone. Patients were randomized to 1~2mg glimepiride or 40~80mg gliclazide depending on the fasting blood glucose level. Doses were increased stepwise, up to 8mg for glimepiride (once-daily) and 320mg for gliclazide (>80 mg as dividedose) respectively, until metabolic control (fasting blood glucose < 7.9 mmol/L) or maximum dose was achieved. The quality of rnetabolic control was assessed by fasting blood glucose and HbA 1c as 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 (3.9
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 hyperglycemia in diabetic patients. As glimepiride was equally effective with single dose, it was expected that this drug may improve patients compliance.
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