EUCTR2006-003630-15-DK进行中（未招募）不适用
The effect of insulin analogues and human insulin on the incidence of severe hypoglycae-mia in hypoglycaemia prone type 1 diabetic patients - HypoAna
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 370
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
- •Male or female aged 18 years
- •Type 1 diabetes for 5 years or more
- •Two or more episodes of severe hypoglycaemia during the preceding year
- •Treated with human insulin or insulin analogues
- •Willingness to do self monitoring of blood glucose (SMBG)
- •Negative pregnancy test
- •Signed informed consent
- •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
- •History of primary and secondary adrenal insufficiency, growth hormone deficiency, or un-treated myxoedema.
- •History of major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last six months.
- •History of malignancy unless a disease free period exceeding five years
- •History of alcohol or drug abuse
- •Pregnant or lactating women.
- •Women of childbearing potential who are not using chemical (P-pills or gestagen depots) or mechanical (intra-uterine device) contraception
- •Participation in another investigational drug study within one month
- •Inability to understand the informed consent
研究者
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