NCT01680978已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)
研究概览
简要总结
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. Eligible patients will receive either 150 mcg aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients will cross over to the treatment not yet received.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 40 to 70 years of age (inclusive) at screening
- •Patients with Type 2 diabetes mellitus diagnosed at least 12 weeks before screening and either drug-naïve or treated with stable metformin monotherapy for at least 12 weeks prior to screening
- •HbA1c >/= 7 % and </= 9% at screening
- •Absence of history of coronary artery disease
排除标准
- •Diagnosis or history of Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- •Current treatment with fibrates, thiazolidinediones, or insulin
- •Prior intolerance to thiazolidinediones and/or fibrates
- •Clinically significant liver disease or impaired liver function
- •Know chronic diabetic complications (i.e. retinopathy, neuropathy, nephropathy)
- •Symptomatic congestive heart failure classified as NYHA class II-IV
- •Diagnosed and/or treated malignancy within the past 5 years, except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
- •Contraindications to MRI, or inability to tolerate MRI scanning
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Aleglitazar
Experimental
干预措施: aleglitazar (Drug)
结局指标
主要结局
Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)
时间窗: from baseline to Week 6
次要结局
- Change in cardiac/hepatic triglyceride content assessed my MRS(from baseline to Week 6)
- Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)(from baseline to Week 6)
研究者
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