CTRI/2012/01/002334已完成3 期
A Multicentric, Comparative Controlled, Open Label, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC containing Orlistat and Metformin with Metformin alone in Obese Type II Diabetic Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocon Ltd
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •i) Male and female patients in the age group of 20-80 years
- •ii) Females of childbearing potential should have a negative pregnancy test at the pre-study visit and agree to use contraception during the study.
- •iii) Patients willing to give informed consent.
- •iv) Mild to moderate obese Type 2 diabetic patient.
- •v) Patients who are willing to comply with all study requirements
排除标准
- •i) Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
- •ii) Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
- •iii) Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study.
- •iv) Women of childbearing potential who are not using effective and medically acceptable methods of contraception.
- •v) Patients who are meeting any of the contraindications of the study medication
研究者
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