NCT00095030已完成3 期
A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Subjects Wtih Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Bristol-Myers Squibb206 个研究点 分布在 2 个国家目标入组 1,752 人开始时间: 2004年2月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,752
- 试验地点
- 206
- 主要终点
- Change in baseline HbA1c after 52 weeks
研究概览
简要总结
The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening
- •HbA1c >or = 7% and < or = 10%
- •Fasting c-peptide > or = 1.0 umol
- •Body Mass Index < or = 41 kg/m2
- •Mean serum triglycerides < or = 600 mg/dl
排除标准
- 未提供
结局指标
主要结局
Change in baseline HbA1c after 52 weeks
次要结局
- Change in lipids after 52 weeks; safety and efficacy when administered with metformin after 52 weeks
研究者
研究点 (206)
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