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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
| Tracking Information | |||
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| 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. |
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| 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 Arms | Experimental: Metformin, Apo-metformin
Intervention: Drug: Metformin |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||
| 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 | ||
| PRS Account | Zanjan University of Medical Sciences | ||
| Verification Date | November 2008 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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