NCT01296438已完成1 期
A Randomised Trial Investigating the Pharmacokinetic Properties of NN1218 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
- 40
- 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 this trial is to investigate the pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin aspart.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus for at least 12 months
- •Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months.
- •Body Mass Index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)
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 trial start
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
研究组 & 干预措施
Treatment sequence 1
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Treatment sequence 2
Active Comparator
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 0-1 hour after trial drug administration
次要结局
- Area under the serum insulin aspart concentration-time curve(from 0-12 hours after trial drug administration)
研究者
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