Diabetes Mellitus, Type 2 AND Metformin
Conditions
Keywords
Diabetes mellitus, type 2, Metformin, Generic, Efficacy
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.
Interventions
DRUGMetformin
Sponsors
Zanjan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes
Exclusion criteria
* Creatinine more than 1.5, severe organ damage
Outcome results
None listed