CTRI/2008/091/000040已完成3 期
A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to AssessGlycemic Control with Rimonabant in Comparison with Glimepiride over 1 Year inOverweight/Obese Type 2 Diabetic Patients Not Adequately Controlled with Metformin - ALLEGRO
SanofiSynthelabo IndiaLtd0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
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
- •?Patients with legal age
- •?Body Mass Index >27kg/m2
- •?Type 2 diabetes as defined by WHO criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three
排除标准
- •?Weight loss > 5 kg within three months prior to screening
- •?Presence of any clinically significant endocrine disease according to the Investigator
- •?Presence of type 1 diabetes
- •?Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
- •?Previous participation in a clinical study with rimonabant
- •?Absence of effective medical contraceptive method for females of childbearing potential
- •?Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
- •?Within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
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