EUCTR2008-001184-11-DE进行中（未招募）不适用
Effect of prandial treatment with insulin VIAjectTM compared to regular human insulin and insulin lispro on postprandial endothelial function and microvascular stress in type 2 diabetic patients
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
- Biodel Inc
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 according to the ADA criteria
- •2. HbA1c between 6.5 % and 9.9 %
- •3. Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
- •4. Age between 40 and 75 years
- •5. BMI < 40
- •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. Type 1 diabetes mellitus
- •2. Pre-treatment with insulin within the last 6 months prior to screening
- •3. Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
- •4. Untreated hypertension stage II-III according to WHO criteria
- •5. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
- •6. Total cholesterol > 300 mg/dl (anamnestically)
- •7. Major micro- or macrovascular complications as judged by the investigator
- •8. Tobacco use within the last 6 months prior to screening
- •9. Drugs with major impact on endothelial function like nitrates etc.
- •10. History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
- •11. History of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •12. History of severe or multiple allergies
- •13. Treatment with any other investigational drug within 3 months prior to screening
- •14. Progressive fatal disease
- •15. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women and > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- •16. Pregnancy or breast feeding
- •17. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
- •18. Lack of compliance or other similar reasonthat at the discretion of the investigator precludes satisfactory participation in the study
- •19. Hypopotassemia (K<3.5 mmol /l)
研究者
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