NCT00849576已完成3 期
Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.
Biodel1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro.
研究概览
简要总结
The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus according to the ADA criteria
- •HbA1c between 6.5 % and 9.9 %
- •Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
- •Age between 40 and 75 years
排除标准
- •Type 1 diabetes mellitus
- •Pre-treatment with insulin within the last 6 months prior to screening
- •Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
- •Untreated hypertension stage II-III according to WHO criteria
- •Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
- •Total cholesterol > 300 mg/dl (anamnestically)
- •Major micro- or macrovascular complications as judged by the investigator
- •Tobacco use within the last 6 months prior to screening
- •Drugs with major impact on endothelial function like nitrates etc.
- •History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
- •History of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •History of severe or multiple allergies
- •Treatment with any other investigational drug within 3 months prior to screening
- •Progressive fatal disease
- •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
- •Pregnancy or breast feeding
- •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
- •Lack of compliance or other similar reason that at the discretion of the investigator precludes satisfactory participation in the study
- •Hypopotassemia (K<3.5 mmol /l)
研究组 & 干预措施
Regular Human Insulin
Active Comparator
Single Injection
干预措施: Regular Human Insulin (Drug)
Inuslin Lispro (90%)
Active Comparator
Single Injection
干预措施: Insulin Lispro (Drug)
Insulin VIAject™ (75%)
Experimental
Single Injection
干预措施: Insulin VIAject™ (75%) (Drug)
Insulin VIAject™ (90%)
Experimental
Single injection
干预措施: Insulin VIAject™ (90%) (Drug)
结局指标
主要结局
Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro.
时间窗: 0 - 240 minutes
次要结局
- The secondary objectives are to evaluate the postprandial time course of arterial elasticity (pulse wave analysis; PWA), blood glucose, insulin, intact proinsulin, nitrotyrosine, glucagon, ICAM-1, VCAM, E-selectin.(0 - 240 minutes)
研究者
研究点 (1)
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