The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co. in Glycemic Control of Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Zanjan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01228240
First received: October 25, 2010
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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. 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.


Condition Intervention
Diabetes Mellitus, Type 2 AND Metformin
Drug: Metformin

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Zanjan University of Medical Sciences:

Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin, Apo-metformin Drug: Metformin

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Creatinine more than 1.5, severe organ damage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01228240     History of Changes
Other Study ID Numbers: 19/3-3/2073
Study First Received: October 25, 2010
Last Updated: October 25, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Zanjan University of Medical Sciences:
Diabetes mellitus, type 2, Metformin, Generic, Efficacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014