NCT00229710终止3 期
An Open-Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 0.5mg When Added to Insulin Therapy in Patients With Type 2 Diabetes Mellitus (GALLEX 9)
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
- 270
- 试验地点
- 69
- 主要终点
- Adverse events
研究概览
简要总结
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 the randomized treatment period in GALLANT 9
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, or neutropenia (low white blood cells)
- •Creatinine levels of above twice the normal range
- •Creatine kinase of 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
- Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
- Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
- Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
- C-reactive protein (CRP)
- Central obesity (waist circumference, hip circumference, waist/hip ratio)
研究者
研究点 (69)
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