NCT00229684终止2 期
A 24-week, Randomised, Parallel-Group, Multi-Centre, Open-Label Study of the Renal Effects of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:
研究概览
简要总结
This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per day on components of renal excretion of creatinine in type 2 diabetics. The study comprises a 2-week enrollment period, followed by a 24-week double blind treatment period and an 8-week follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 45 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 >=45 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 twice the normal range
- •Creatine kinase above 3 times the upper limit of normal
- •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
Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:
Glomerular filtration rate (GFR) by iothalamate clearance
Endogenous creatinine clearance
次要结局
- Effects of on tubular secretion of creatinine in type 2 diabetics after 24 weeks of treatment as assessed through determinations of:
- GFR by iothalamate clearance
- Endogenous creatinine clearance
- The time course of change in serum creatinine concentration and GFR during a 24-week period of tesaglitazar treatment in type 2 diabetics
- The effects of tesaglitazar on urinary protein excretion in type 2 diabetics by comparisons of urinary total protein and albumin excretion rates
- The effects of tesaglitazar on urinary creatinine excretion in type 2 diabetics by comparisons of urinary total creatinine excretion rates
- The pharmacokinetics of tesaglitazar during 24 weeks of therapy in type 2 diabetics.
- The safety and tolerability of tesaglitazar in type 2 diabetics by assessments of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, body weight, and physical examination.
研究者
研究点 (20)
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