EUCTR2010-018619-14-DE进行中（未招募）不适用
Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus - Lira-Vasc-001
ikfe GmbH0 个研究点开始时间: 2010年2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. Diabetes Mellitus type 2
- •2. HbA1c = 5.5% and = 7.0%
- •3. Treatment with Metformin (daily dose 500 – 3000 mg monotherapy, the past 3 months)
- •4. Age 30 – 65 years
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pre-treatment with PPAR gamma agonists or DPP IV inhibitors or GLP-1 analogues within the last three months
- •2. History of type 1 Diabetes Mellitus
- •3. No full legal mental and physical ability to give informed consent
- •4. Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg)
- •5. Anamnestic acute and chronic infections
- •6. Anamnestic history of epilepsy
- •7. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •8. History of severe or multiple allergies
- •9. Treatment with any other investigational drug within 3 months before trial entry
- •10. Progressive fatal disease
- •11. History of drug or alcohol abuse in the past 2 years
- •12. Liver disease with ASLT or ALT above 3 times the upper normal limit
- •13. Serum potassium > 5.5 mmol/L
- •14. Moderate to Servere Kidney disease with a GFR = 60 ml/min
- •15. Pregnancy or breast feeding
- •16. Sexually active woman of childbearing potential 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
- •17. 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
- •18. History of dehydration, diabetic precoma, diabetic ketoacidosis or diabetic gastroparesis
- •19. Acute (within the previous 2 days) or scheduled investigation with iodine containing radiopaque material
- •20. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 6 months
- •21. Anamnestic uncontrolled unstable angina pectoris, pericarditis, myocarditis, endocarditis, haemodynamic relevant aortic stenosis or aortic aneurysma
- •22. Anamnestic recent pulmonary embolism or pulmonary insufficiency
- •23. Smoking within the last 6 months (< 1 cigarette/day)
- •24. Planned change in antidiabetic, lipid lowering or blood pressure medication
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