NCT00263965终止2 期
A 16-Week Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo- and Active- (Metformin) Controlled Study to Evaluate the Effect on Whole Body Insulin Sensitivity of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes
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
- 105
- 试验地点
- 3
- 主要终点
- Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
研究概览
简要总结
This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.
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
- 30 Years 至 70 Years（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 30-70 years of age
- •Female patients: postmenopausal, hysterectomized
- •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
Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
次要结局
- Liver oxidation after a mixed meal
- Energy expenditure and substrate metabolism by indirect calorimetry
- Calculated insulin secretion
- Safety and tolerability of tesaglitazar in patients with type 2 diabetes.
- Body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy
- Laboratory efficacy variables (lipids, inflammatory marker and adipose tissue hormones)
- Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
- Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp.
- Plasma profile of glucose, insulin and lipids after a mixed meal
- Waist and hip circumference
研究者
研究点 (3)
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