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The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co. in Glycemic Control of Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01228240
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : October 26, 2010
Sponsor:
Information provided by:
Zanjan University of Medical Sciences

Brief 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. 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.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 AND Metformin Drug: Metformin

Study Type : Interventional  (Clinical Trial)
Study Start Date : December 2008
Primary Completion Date : July 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metformin, Apo-metformin Drug: Metformin




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes

Exclusion Criteria:

  • Creatinine more than 1.5, severe organ damage

ClinicalTrials.gov Identifier: NCT01228240     History of Changes
Other Study ID Numbers: 19/3-3/2073
First Posted: October 26, 2010    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: November 2008

Keywords provided by Zanjan University of Medical Sciences:
Diabetes mellitus, type 2, Metformin, Generic, Efficacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs