Comparison of a generic and a brand metformin products in type II diabetes: A double blind randomized clinical trial study

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Abstract:
Metformin is often prescribed for glycemic control in type II diabetes mellitus. This drug is the first line treatment for obese without renal or liver failure. Different pharmaceutical types of Metformin are available. As a clinical trial, therapeutic effects of a generic (Aria Pharmaceutical Company, Iran) with a brand metformin (Glucophage, product of Merck pharmaceutical company, France) in diabetic patients were compared. This double blind randomized clinical trial study was performed in 60 non-pregnant diabetic patients in order to compare therapeutic effects of combination therapy (Glibenclamide - Metformin "Generic or Brand" a 12-week period). Patients were evaluated for FBS, BS2hpp, HbA1C, lipid profile, liver function tests, weight, BMI, and side effects. Both pharmaceutical types of Metformin had the same therapeutic effects for controlling of glycemia, and lipid profile and weight, between two groups statistically were not significantly different. GI discomfort (distention) was the most common side effects of both drugs (33%). There were no significant statistical differences between these two products regarding their side effects and 70% of patients were satisfied by taking each kind of product. On the basis of results, while both products had comparable efficacy, the generic product which is a domestic product and easier for patients to have access to it showed fewer side effects.
Language:
English
Published:
DARU, Journal of Pharmaceutical Sciences, Volume:15 Issue: 2, Summer 2007
Pages:
113 to 117
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