EUCTR2012-001639-29-GB进行中（未招募）不适用
A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of Aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin monotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and women 40 to 70 years of age;
- •T2D patients either drug-naïve (i.e., treated with diet and exercise) or treated with stable metformin monotherapy;
- •HbA1c = 7.0% and = 9.0%;
- •absence of history of coronary artery disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Treatment with fibrates, TZDs or insulin;
- •intolerance to thiazolidinediones, and/or fibrates;
- •known chronic diabetic complications;
- •clinically significant hepatic disease and/or liver tests abnormalities;
- •symptomatic congestive heart failure classified as NYHA class II-IV;
- •malignancy within the past 5 years.
研究者
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