NCT00261352终止3 期
A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 1,000
- 试验地点
- 147
- 主要终点
- The change in HDL-C from baseline to the end of the randomized treatment period.
研究概览
简要总结
This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of a written informed consent
- •Men or women who are >=18 years of age
- •Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
- •Diagnosed with type 2 diabetes
- •Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
排除标准
- •Type 1 diabetes
- •New York Heart Association heart failure Class III or IV
- •Treatment with chronic insulin
- •History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
- •History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
- •Creatinine levels above the normal range
- •Received any investigational product in other clinical studies within 12 weeks
- •Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
结局指标
主要结局
The change in HDL-C from baseline to the end of the randomized treatment period.
次要结局
- Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
- Pharmacokinetics of tesaglitazar
- Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
- Central obesity (waist/hip ratio)
- The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
- Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
- Changes in the following variables from baseline to the end of the randomized treatment period:
- Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
研究者
研究点 (147)
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