drugset / Trial / NCT01228240

The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.

NCT01228240 ↗

Phase 4 Completed 18 enrolled Zanjan University of Medical Sciences
RandomizedCrossoverSingle-blindTreatment

Summary

Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus. Different pharmaceutical types of metformin are available. As a clinical trial, we compared the efficacy and complications of metformin produced by "Pars Mino pharmaceutical company, Iran" with "Apotex pharmaceutical company, Canada", in type 2 diabetic patients. Method: 18 eligible women with type 2 diabetes were given metformin "Pars Mino" or "Apotex" (500 mg twice a day) each for 6 weeks period in a randomized, double blind, crossover study. These two groups randomly under treatment with generic metformin (manufactured by Pars Mino company) or non-generic (manufactured by Apotex Canada). After 2 weeks washout period another 6 weeks period with another Brand of metformin was prescribed. FBS, HbA1C, lipid profile (Cholesterol, TG, HDL, and LDL), weight, and BMI were assessed before and after each treatment phase. The results were compared with each other by paired sample T-test, Independent sample T-test.

Timeline

Start
2008-12
Primary completion
2009-07
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg —