NCT01138488已完成1 期
A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults 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
- 38
- 试验地点
- 1
- 主要终点
- Area under the serum insulin degludec concentration-time curve
研究概览
简要总结
This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2
排除标准
- •Subject who has donated any blood or plasma in the past month, or more than 500 mL within 3 months prior to screening
- •Not able or willing to refrain from smoking during the inpatient period
- •Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
研究组 & 干预措施
NN5401
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Area under the serum insulin degludec concentration-time curve
时间窗: from 0 to infinity after single-dose
Area under the serum insulin aspart concentration-time curve
时间窗: from 0 to 12 hours after single-dose
次要结局
- Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed(from 0 to 57 hours after single-dose)
- Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed(from 0 to 12 hours after single-dose)
研究者
研究点 (1)
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