NCT00280865已完成2 期
Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 500
- 试验地点
- 110
- 主要终点
- Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
研究概览
简要总结
This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period
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 50 Years（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 to 80 years of age
- •Female patients: postmenopausal or surgically sterile
- •Diagnosed with type 2 diabetes with C-peptide levels > 0.8 ng/mL
- •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), or to other PPAR g or PPAR a and g agonists.
- •History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
- •Creatinine levels above 1.2 mg/dL
- •Received any investigational product in other clinical studies within 30 days
- •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
Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
次要结局
- Pharmacokinetics of tesaglitazar
- Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
- Responder analyses for FPG, TG, and HDL C according to pre-specified values
- Changes in the following variables from baseline to the end of the randomized treatment period:
- To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r
- The change in plasma glucose and insulin during an oral glucose tolerance test
- Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids
- Change in insulin levels and hemoglobin A1c (HbA1c) levels
- To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data
研究者
研究点 (110)
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