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:

Information provided by:

Zanjan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01228240

First received: October 25, 2010

Last updated: NA

Last verified: November 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 25, 2010
Last Updated Date	October 25, 2010
Start Date ^ICMJE	December 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co. in Glycemic Control of Diabetic Patients
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Diabetes Mellitus, Type 2 AND Metformin
Intervention ^ICMJE	Drug: Metformin
Study Arm (s)	Experimental: Metformin, Apo-metformin Intervention: Drug: Metformin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	September 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes Exclusion Criteria: Creatinine more than 1.5, severe organ damage
Gender	Female
Ages	30 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Not Provided
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01228240
Other Study ID Numbers ^ICMJE	19/3-3/2073
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Zanjan University of Medical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Zanjan University of Medical Sciences
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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