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

NCT01228240 | Completed Phase 4

• 1 other identifier: 19/3-3/2073
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2 AND Metformin

Keywords

Diabetes mellitus, type 2, Metformin, Generic, Efficacy

Study Arms (2)

Metformin, Apo-metformin

EXPERIMENTAL

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

Drug: Metformin

Metformin, Pars Minoo

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

Metformin DRUG

Metformin, Apo-metformin; Metformin, Pars Minoo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Creatinine more than 1.5, severe organ damage

Sponsors & Collaborators

• Zanjan University of Medical Sciences: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 18, 2023

Record last verified: 2023-07