EUCTR2005-003877-26-HU进行中（未招募）不适用
Comparison of the effect of insulin detemir and NPH insulin on dawn phenomenon in patients with Type 1 diabetes An open-labelled, randomised, cross-over, multi-center trial comparing the effect of insulin detemir versus NPH insulin as basal insulins on dawn phenomenon and the glycaemic control in patients with Type 1 diabetes treated on a basal-bolus regimen - Dawn phenomenon – insulin detemir
ational Centre for Diabetes Care, 1st Dept. Medicine, Diabetes Unit0 个研究点开始时间: 2006年1月25日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 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
- •Subjects with type 1 diabetes mellitus
- •Subjects =< 35 years of age at diagnosis
- •Currently on basal-bolus treatment with any basal and bolus insulins (start of insulin therapy within 1 year after diagnosis)
- •Age between 18 and 60 years (both inclusive)
- •Verified dawn phenomenon
- •BMI =< 35.0 kg/m2
- •HbA1c between 7.0 and 10.0% (both inclusive)
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with proliferative retinopathy or maculopathy requiring acute treatment within the last 6 months
- •Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and mono amine oxidase (MAO) inhibitors
- •Impaired hepatic or renal function that according to the Investigator will interfere with trial participation
- •Known or suspected allergy to trial products or related products
- •Previously screened in this trial
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
研究者
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