NCT02035371已完成1 期
A Trial Investigating the Pharmacokinetic Properties of FIAsp 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
- 41
- 试验地点
- 1
- 主要终点
- Area under the serum insulin aspart concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of FIAsp (faster-acting insulin aspart) in children, adolescents and adults 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 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults equal to or below 28.0 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
- •Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- •Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
研究组 & 干预措施
FIAsp
Experimental
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
干预措施: Faster-acting insulin aspart (Drug)
NovoRapid®
Active Comparator
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the serum insulin aspart concentration-time curve
时间窗: From 0 to 12 hours
次要结局
- Maximum observed serum insulin aspart concentration(From 0-12 hours)
研究者
研究点 (1)
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