NCT00297063已完成3 期
Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo -
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 14
- 主要终点
- HbA1c change from baseline at Week 28.
研究概览
简要总结
This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus.
- •Managed by diet therapy.
- •Must have adequate blood, liver and kidney function.
排除标准
- •Serious cardiovascular disease or serious hepatic disease.
结局指标
主要结局
HbA1c change from baseline at Week 28.
时间窗: 28 Weeks
次要结局
- Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.(28 Weeks)
研究者
研究点 (14)
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