EUCTR2005-004775-38-DK进行中（未招募）不适用
A comparison of pharmacodynamics and pharmacokinetics of Insulin Aspart and Biphasic Insulin Aspart 30, 50 og 70. A quadruple cross-over trial. - Asp-BIAsp-2005/0109
Medicinsk Afd. M, Århus Sygehus, Nørrebrogade0 个研究点目标入组 24 人开始时间: 2008年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- •- Informed consent.
- •- Diagnosed with type 1 diabetes before the age of 40.
- •- In treatment with any insulin > 1 year.
- •- Total insulin demand > 0,5 IU/kg/24 hrs.
- •- HbA1c between 7-12% (both included).
- •- Age > 18 years.
- •- BMI between 18-35 kg/m2 (both included).
- •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
- •- Known or suspected allergy to the trial products or related products.
- •- Recurrent major hypoglycaemic episodes.
- •- Heart: Unstable Angina Pectoris, AMI < 12 months or heart insufficiency classified according to NYHA III-IV.
- •- Blood pressure: Severe uncontrolled hypertension with BP>180/110 mmHg, sitting.
- •- Liver: Impaired hepatic function corresponding to serum-ALAT or -basic phosphatase > 2x upper reference limit of the local laboratory.
- •- Kidneys: Impaired renal function by serum-creatinin > 150 µmol/l according to the local laboratory.
- •- Any disease judget by investigator to affect the trial.
- •- Pregnancy, breast feeding or intention of becoming pregnant or not using adequate contraceptive measures.
- •- The receipt of any inverstigational drug within a three month period prior to this trial.
研究者
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