Clinical Assessment of Glimepiride (Amaril®) in the Treatment of Type 2 Diabetes Mellitus Patients (Results of a Multicenter Study)

Issue: 1/2002

Abstract: 

Glimepiride (Amaryl®) is a new long-acting, third generation sulfonylurea preparation, given once daily. It is the purpose of this multicenter study to evaluate the efficacy, safety and tolerance of glimepiride given as monotherapy in type 2 diabetic patients. A total of 75 patients (51 men and 24 women), mean age 56 ± 7,7 years, diabetes duration 4 ± 1,4 years, inadequately controled by diet, physical exercises or hypoglycemic agents are covered by the study. Also assessed are body weight and lipid profile, with special emphasis on eventual adverse reactions.

Analysis of the results: From baseline to end-point, mean fasting plasma glucose decreased from 10,3 ± 2,3 to 6,9 ± 1,5 mmol/l (p < 0,01), mean postprandial plasma glucose – from 11,4  ±  3,1 to 8,6 ± 1,6 mmol/l (p < 0,01) and mean HbA_1c (%) – from 8,6 ± 2,4 to 7,5 ± 1,5 % (p < 0,05). Body mass index also decreased from 27,7 ± 4,3 kg/m² to 27,1 ±4,0 kg/m² (p < 0,05) throughout the study period. Regarding lipid analysis there are no significant changes in lipid control parameters. The mean daily dose of glimepiride at termination of the study is 2,1 ± 0,3 mg, required by 85% of patients. There is only one moderate hypoglycemic episode, recorded at the beginning of study.

Conclusions: Glimepiride (Amaryl®) is effective, well tolerated with minimal side effects during treatment of inadequately controlled type 2 diabetic patients, contributing also to a moderate body weight reduction.

Keywords: glimepiride, glycemic control, diabets.

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