The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2 AND Metformin
• Interventions: Drug: Metformin

• Registration Number: NCT01228240
• Lead Sponsor: Zanjan University of Medical Sciences

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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes

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Exclusion Criteria

• Creatinine more than 1.5, severe organ damage

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin, Apo-metformin	Metformin	Participants under treatment with non-generic Metformin (manufactured by Apotex Canada).
Metformin, Pars Minoo	Metformin	Participants under treatment with generic Metformin (manufactured by Pars Minoo).