NCT00251940终止3 期
A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone
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
- 555
- 试验地点
- 85
- 主要终点
- Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
研究概览
简要总结
This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-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
- 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
- •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
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
次要结局
- • Waist/hip ratio
- Changes in the following variables from baseline to the end of the randomized treatment period:
- • The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
- • Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
- • 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, lipoprotein particle size and c
- • C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
- • FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
- • Tumor necrosis factor-alpha, intracellular adhesion molecule-1
- • Fibrinogen
- • Urinary albumin excretion
- • Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
- • Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
- • Pharmacokinetics of tesaglitazar
- • 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
研究者
研究点 (85)
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