EUCTR2007-006744-21-DE进行中（未招募）不适用
Comparison of the Effects of Pioglitazone vs. Placebo when given in addition to Standard Insulin Treatment in Patients with Type 2 Diabetes Mellitus and Renal Failure – The PIOren Study - PIOren Study
Takeda Pharma GmbH0 个研究点开始时间: 2008年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Type 2 diabetes mellitus 2. Age 30-80 years 3. BMI < 36 kg/m² 4. HbA1c > 6.5 % (HbA1c-values determined maximal 2 weeks prior to screening visit are acceptable to fulfil this inclusion criterion) 5. Patient is on hemo-dialysis with or without residual excretion 6. Insulin dose > 20 IE/day 7. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of type-1-diabetes 2. Acute infections 3. History of hypersensitivity to the study drugs or to drugs with similar chemical structures 4. History of severe or multiple allergies 5. Treatment with any other investigational drug within 3 months before trial entry. 6. Treatment with steroids within 3 months before trial entry. 7. Progressive fatal disease other than kidney failure 8. History of drug or alcohol abuse within the last 5 years 9. A history of significant cardiovascular (e.g. CHF NYHA stage III – IV), respiratory, gastrointestinal, hepatic (e.g. ALAT > 2.5 times the normal reference range), haematological disease 10. History of primary hyperaldosteronism 11. Pregnancy or breast feeding 12. Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. 13. Treatment with thiazolidinediones within the past 3 months 14. Acute myocardial infarct, open heart surgery or cerebral event (stroke/TIA) within the previous 30 days
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