EUCTR2007-006706-14-DE进行中（未招募）不适用
Impact of Pioglitazone, Metformin and the combination of both on cardiovascular risk in insulin-treated patients with Type 2 diabetes – The PIOcomb Study - PIOcomb Study
Takeda Pharma GmbH0 个研究点开始时间: 2008年1月24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. Diabetes mellitus type 2
- •2. HbA1c >= 6.5% <= 8.5%
- •3. Treatment with the following insulins with or without OAD Therapy since 3 months:
- •a. Long acting basal insulin analogs,
- •b. NPH insulin,
- •c. Combination insulin with 1-2 daily doses; except intensified insulin therapies
- •4. Age 30 – 75 years
- •5. BMI >= 25
- •6. 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 mellitus
- •2. Uncontrolled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >95mmHg), change of antihypertensive treatment within the last 2 weeks
- •3. Acute infections
- •4. NSAIDs (incl. low dose ASA) or Cox-2-inhibitors if therapy initiated within the last 4 weeks
- •5. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structure
- •6. History of severe or multiple allergies
- •7. Treatment with any other investigational drug within 4 weeks before trial entry
- •8. History of drug or alcohol abuse in the past 5 years
- •9. A history of significant cardiovascular (NYHA stage I - IV; determined by anamnesis and clinical status), respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 2.5 times the upper limit of the normal reference range), renal (serum creatinine > 1.2 mg/dL in women and > 1.5 mg/dL in men, GFR < 60 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or haematological disease as judged by the investigator
- •10. History of macular oedema
- •11. State after kidney transplantation
- •12. Serum potassium > 5.5 mmol/L
- •13. History of primary hyperaldosteronism
- •14. Pregnancy or breast feeding
- •15. 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
- •16. Treatment with thiazolidinediones within the past 3 months
- •17. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous year
- •18. Any elective surgery during study participation
- •19. If statin therapy applicable: Change of medication within the last 4 weeks
- •20. Pre-treatment with gemfibrozil within the last 12 weeks
- •21. Pre-treatment with rifampicin within the last 12 weeks
- •22. Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypoglycaemia) within 6 months prior to screening visit
- •23. History of dehydration, precoma diabeticum or shock or diabetic ketoacidosis within the past year prior to screening visit
- •24. Acute or scheduled investigation with iodine containing radiopaque material
- •25. Uncontrolled unstable angina pectoris
- •26. Medical history of acute and clinically relevant pericarditis, myocarditis, endocarditis, recent pulmonary embolism, hemodynamic relevant aortic stenosis, aortic aneurysm
- •27. Postmenopausal woman with present osteoporosis
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