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

July 14, 2023 updated by: Majid Valizadeh, Zanjan University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Creatinine more than 1.5, severe organ damage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin, Apo-metformin
Participants under treatment with non-generic Metformin (manufactured by Apotex Canada).
Drug: Metformin
Active Comparator: Metformin, Pars Minoo
Participants under treatment with generic Metformin (manufactured by Pars Minoo).
Drug: Metformin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zanjan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimated)

October 26, 2010

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/3-3/2073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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