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

Tracking Information
First Submitted Date ICMJE	October 25, 2010
First Posted Date ICMJE	October 26, 2010
Last Update Posted Date	October 26, 2010
Study Start Date ICMJE	December 2008
Actual 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 Applicable
Study Design ICMJE	Not Provided
Condition ICMJE	Diabetes Mellitus, Type 2 AND Metformin
Intervention ICMJE	Drug: Metformin
Study Arms	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
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	September 2009
Actual 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
Sex/Gender	Sexes Eligible for Study: 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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Zanjan University of Medical Sciences
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	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