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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228240
First Posted: October 26, 2010
Last Update Posted: October 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zanjan University of Medical Sciences
  Purpose

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 Intervention
Diabetes Mellitus, Type 2 AND Metformin Drug: Metformin

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Zanjan University of Medical Sciences:

Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin, Apo-metformin Drug: Metformin

  Eligibility

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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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT01228240     History of Changes
Other Study ID Numbers: 19/3-3/2073
First Submitted: October 25, 2010
First Posted: October 26, 2010
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