NCT02536859已完成1 期
A Randomised, Single-centre, Double-blind, Two-period Cross-over, Multiple Dose Trial Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
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
- 60
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.
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 18.5-29.0 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 screening
- •Smoker (defined as a subject who is smoking more than 5 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 in-patient period
研究组 & 干预措施
IDeg
Experimental
干预措施: insulin degludec (Drug)
IGlar U300
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve
时间窗: During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12
次要结局
- Area under the glucose infusion rate curve(During one dosing interval at steady state.At day 6, 9 and 12)
研究者
研究点 (1)
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