A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- CSII bolus related baseline corrected 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 compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-64 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) 18.5-28.0 kg/m^2 (both inclusive)
- •Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
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 followed by NovoRapid®
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® followed by FIAsp
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
CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve
时间窗: From 0 to 30 minutes
次要结局
- CSII bolus related baseline corrected area under the glucose infusion rate curve(From 0 to 1 hour)
- CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve(From 0 to 1 hour)