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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
October 25, 2010
October 26, 2010
October 26, 2010
December 2008
July 2009   (Final data collection date for primary outcome measure)
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No Changes Posted
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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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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.
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Interventional
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Diabetes Mellitus, Type 2 AND Metformin
Drug: Metformin
Experimental: Metformin, Apo-metformin
Intervention: Drug: Metformin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Creatinine more than 1.5, severe organ damage
Sexes Eligible for Study: Female
30 Years to 80 Years   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
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NCT01228240
19/3-3/2073
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Zanjan University of Medical Sciences
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Zanjan University of Medical Sciences
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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