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

Zanjan University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2 AND Metformin

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01228240

19/3-3/2073

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Creatinine more than 1.5, severe organ damage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Metformin, Apo-metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Metformin, Pars Minoo

Active Comparator group

Description:

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

Treatment:

Drug: Metformin