NCT02568280已完成1 期
A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects 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
- 42
- 试验地点
- 1
- 主要终点
- Mean change in plasma glucose concentration
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects 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
- 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
- •Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
- •Body mass index 18.5-28.0 kg/m^2 (both inclusive)
排除标准
- •Smoker (defined as a subject who is smoking at least five cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
研究组 & 干预措施
Faster aspart
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Insulin aspart
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Mean change in plasma glucose concentration
时间窗: From 0-1 hour after trial product administration
次要结局
- Rate of endogenous glucose production(From 0-6 hours after trial product administration)
- Area under the serum insulin aspart concentration-time curve(From 0-6 hours after trial product administration)
研究者
研究点 (1)
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