NCT01773798已完成1 期
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 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
- 33
- 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 the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 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
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index 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 screening
- •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, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
- •Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)
研究组 & 干预措施
IDegAsp 15
Experimental
干预措施: insulin degludec/insulin aspart 15 (Drug)
IDegAsp 15
Experimental
干预措施: placebo (Drug)
IDegAsp
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
IDegAsp
Experimental
干预措施: placebo (Drug)
IDeg
Experimental
干预措施: insulin degludec (Drug)
IAsp
Active Comparator
干预措施: insulin aspart (Drug)
IDeg + IAsp
Experimental
干预措施: insulin degludec (Drug)
IDeg + IAsp
Experimental
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve
时间窗: From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp)
次要结局
- Area under the serum IDeg concentration-time curve(From 0 to 120 hours after single dose)
- Area under the serum IAsp concentration-time curve(From 0 to 12 hours after single dose)
研究者
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