NCT00300105终止3 期
A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar Therapy in Patients With Type 2 Diabetes
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
- 400
- 试验地点
- 42
- 主要终点
- Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
研究概览
简要总结
This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 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
- 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
- •Completed the last two visits of randomized treatment period in GALLANT 4
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
- •Previous enrollment in this long-term extension study
- •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
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
次要结局
- Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
- Time to treatment failure
- Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
- Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
- Markers of insulin resistance by assessment of insulin homeostasis assessment model
- Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
- Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
- Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
- Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
- Urinary albumin excretion
- Central obesity (waist circumference, hip circumference and waist/hip ratio)
研究者
研究点 (42)
Loading locations...
相似试验
终止
3 期
GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00226330AstraZeneca1,100
终止
3 期
GALLEX 1 - Long Term Extension Study in Patients With Type 2 DiabetesType 2 DiabetesNCT00252876AstraZeneca2,000
终止
3 期
GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00229710AstraZeneca270
终止
2 期
ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR)Diabetes Mellitus, Type 2NCT00229684AstraZeneca100
已完成
3 期
A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and SafetyDiabetesNCT02491528Tonghua Dongbao Pharmaceutical Co.,Ltd563