The Efficacy of Metformin Produced by Pars Mino Co in Comparison With Canadian Apotex Co.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mild hyperglycemia, no contraindication for metformin, poor controlled diabetes
排除标准
- •Creatinine more than 1.5, severe organ damage
研究组 & 干预措施
Metformin, Apo-metformin
Participants under treatment with non-generic Metformin (manufactured by Apotex Canada).
干预措施: Metformin (Drug)
Metformin, Pars Minoo
Participants under treatment with generic Metformin (manufactured by Pars Minoo).
干预措施: Metformin (Drug)
研究者
Majid Valizadeh
Professor
Zanjan University of Medical Sciences