EUCTR2011-005702-30-DK进行中（未招募）1 期
Interactions between exogenous Insulin Aspart, endogenous insulin and plasma glucose in type 2 diabetes mellitus patients - Endogenous insulin Jurgita II-2011/1811
Aarhus University Hospital, Department of Endocrinology and Internal Diseases0 个研究点开始时间: 2011年12月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Signed and dated informed consent
- •Type 2 diabetes according to the WHO classification for at least 6 months
- •Insulin-naive patients who have never been treated with insulin
- •HbA1c < 9% according to the local laboratory
- •Women and men = 35 og = 75 years old
- •BMI between25 kg /m2 og 42 kg /m2, both values are 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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Suspected or known allergy to the trial drug or similar medications
- •Treatment with the drugs that after investigator judgment could potentially interfere with plasma glucose levels
- •Heart: Unstable angina pectoris, AMI < 12 months old or severe heart failure according to NYHA III-IV
- •BP: Severe uncontrolled hypertension with BP > 180/110 mmHg (in lying position)
- •Liver: Impaired liver function with plasma ALAT or alkaline phosphatase levels > 2 times the upper normal limit according to the local laboratory
- •Kidneys: eGFR< 50 ml/min/l according to the local laboratory
- •Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.
研究者
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