Trial | NCT01228240  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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 Started
Dec 31
2008
Primary Completion
Jul 31
2009
Study Completion
Sep 30
2009
Last Update
Jul 18
2023

Drug Metformin

Metformin, Apo-metformin Experimental

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

Metformin, Pars Minoo Active Comparator

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

Criteria 

Inclusion Criteria:

Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes

Exclusion Criteria:

Creatinine more than 1.5, severe organ damage
No Results Posted