NCT00361868终止3 期
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 70
- 主要终点
- HbA1c/TG
研究概览
简要总结
Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.
排除标准
- •Type 1 diabetes.
研究组 & 干预措施
1
Experimental
干预措施: fenofibrate (F) + metformin (M) hydrochloride fixed combination (Drug)
2
Active Comparator
干预措施: Rosiglitazone (Drug)
结局指标
主要结局
HbA1c/TG
时间窗: 24 weeks
次要结局
- Lipid and glycemic parameters.(24 weeks)
研究者
研究点 (70)
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