NCT01497574已完成1 期
A Single-centre, Randomised, Double-blind, Cross-over Trial Comparing the Within-subject Variability of the Pharmacokinetic Profiles of Insulin Detemir and Insulin Glargine in Children and Adolescents With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the insulin concentration curve (AUC)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least 12 months
- •Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m^2 (both inclusive)
- •Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m^2 (both inclusive)
- •HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results
- •Current treatment with insulin at least twice daily
排除标准
- •Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes
- •Receipt of any investigational product within the last four weeks
- •Known or suspected allergy to trial products or related products
研究组 & 干预措施
Insulin detemir
Experimental
干预措施: insulin detemir (Drug)
Insulin detemir
Experimental
干预措施: insulin glargine (Drug)
Insulin glargine
Active Comparator
干预措施: insulin detemir (Drug)
Insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Area under the insulin concentration curve (AUC)
次要结局
- Maximum insulin concentration (Cmax)
- Time to maximum insulin concentration (tmax)
- Adverse events
研究者
研究点 (1)
Loading locations...
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