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Clinical Trial Of Glimepiride Compared With Glibenclamide For Efficacy And Safety In Type 2 Diabetes Mellitus In Jos, Nigeria
Objective: The study was undertaken to compare the efficacy and safety of Glimepiride against Glibenclamide in the management of patients with type 2 DM in Jos, Nigeria.
Study design: An open, randomised controlled trial.
Setting: Diabetes Clinic of the Jos University Teaching Hospital, Jos, Nigeria.
Subjects: Seventy four type 2 diabetic patients were randomised to either Glimepiride or Glibenclamide for at least 12 weeks.
Measurements: Fasting plasma glucose (Primary outcome variable) and fasting plasma total cholesterol (TC), triglycerides (TG), HDL-cholesterol, and compliance (Secondary outcome variables) were the efficacy variables of interest. Adverse events and the laboratory variables of full blood count, liver function tests, electrolytes, urea, uric acid, and creatinine were the safety outcome variables.
Results: Satisfactory blood glucose control was achieved in the majority (88.7%) of patients on 1-6mg Glimepiride daily and 5 to 20mg Glibenclamide daily. The proportion of patients who had good blood glucose control was significantly higher in the Glimepiride-treated group (85.7%) than in the cohort treated with Glibenclamide (52.8%), P<0.05. Patients on Glimepiride had significantly lower mean plasma cholesterol, (total, LDL, HDL) and triglycerides post-trial than at baseline. Both drugs were metabolically inert and did not derange the haematological and/ or biochemical profiles of the patients. No side effects were observed and there was absence of hypoglycaemic episodes.
Conclusion: Glimepiride 1-6mg once daily and Glibenclamide 5-20mg daily are effective medications for Nigerians with type 2 DM.
Keywords: Diabetes mellitus, Glycaemic control, Glibenclamide, Glimepiride, Nigerians
Highland Medical Research Journal Vol. 5 (1) 2007 pp. 61-68