CTRI/2008/091/000071已完成3 期
A randomized, double-blind, placebo-controlled, parallel-group, multicenter 12-week study assessing theefficacy and safety of AVE0010 in patients with type 2 diabetes not treated with antidiabetic agents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 4
- 主要终点
- Absolute change from baseline in HbA1c
研究概览
简要总结
Trial was conducted in 15 countries all over the world. A total of 28 patients were randomised from India. Data base for the study has been locked on world wide basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 diabetes mellitus not treated with any antidiabetic agent.
排除标准
- •(1) HbA1c < 7% or > 10% (2) Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control (3) Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study (4) Body mass index < 20 kg/m2 (5) Weight change of more than 5 kg during the 3 months preceding the study.
- •(6) Participation in any previous study with AVE0010 (7) Use of any investigational drug within 3 months prior to study.
结局指标
主要结局
Absolute change from baseline in HbA1c
时间窗: 12 Weeks
次要结局
- Change from baseline in body weight(12 Weeks)
- Change from baseline in fasting plasma glucose(12 Weeks)
- Change from baseline in 2-hours post-prandial plasma glucose(12 Weeks)
研究者
研究点 (4)
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