The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co. in Glycemic Control of Diabetic Patients
Overview[ - collapse ][ - ]
| 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 | Diabetes Mellitus, Type 2 AND Metformin |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Zanjan University of Medical Sciences |
| Responsible Party | Zanjan University of Medical Sciences |
| ClinicalTrials.gov Identifier | NCT01228240 |
| First Received | October 25, 2010 |
| Last Updated | October 25, 2010 |
| Last verified | November 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 25, 2010 |
|---|---|
| Last Updated Date | October 25, 2010 |
| Start Date | December 2008 |
| Estimated Primary Completion Date | September 2009 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co. in Glycemic Control of Diabetic Patients |
|---|---|
| Official Title | 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 | Interventional |
| Study Phase | N/A |
| Study Design | N/A |
| Condition | Diabetes Mellitus, Type 2 AND Metformin |
| Intervention | Drug: Metformin |
| Study Arm (s) | Experimental: Metformin, Apo-metformin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | September 2009 |
| Estimated Primary Completion Date | July 2009 |
| Eligibility Criteria | 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 |
| Accepts Healthy Volunteers | Not Provided |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01228240 |
|---|---|
| Other Study ID Numbers | 19/3-3/2073 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Zanjan University of Medical Sciences |
| Study Sponsor | Zanjan University of Medical Sciences |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | November 2008 |