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

NCT ID: NCT01228240

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 AND Metformin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Metformin, Apo-metformin

Participants under treatment with non-generic Metformin (manufactured by Apotex Canada).

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin, Pars Minoo

Participants under treatment with generic Metformin (manufactured by Pars Minoo).

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Creatinine more than 1.5, severe organ damage
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zanjan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Majid Valizadeh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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19/3-3/2073

Identifier Type: -

Identifier Source: org_study_id

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