NCT Number: NCT01228240
The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.
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. These two groups randomly under treatment with generic metformin (manufactured by Pars Mino company) or non-generic (manufactured by Apotex Canada). 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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Notify MeKey information
Conditions
Age range
30 year–80 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes
Exclusion criteria
- Creatinine more than 1.5, severe organ damage
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Zanjan University of Medical Sciences
Other
Registry information
Important dates
- Study start
- 2008
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Oct 26, 2010
- Registry last updated
- Jul 18, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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