NCT01174303已完成1 期
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Young Adults and Geriatric Subjects With Type 1 Diabetes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area under the Glucose Infusion Rate curve (only for NN5401)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index 18.0-28.0 kg/m^2 (both inclusive)
- •HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis
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 and use of nicotine gum or transdermal nicotine patches during the inpatient period
研究组 & 干预措施
IDegAsp - BIAsp
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
IDegAsp - BIAsp
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
BIAsp - IDegAsp
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
BIAsp - IDegAsp
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Area under the Glucose Infusion Rate curve (only for NN5401)
时间窗: from 0 to 24 hours after single-dose administration
次要结局
- Area under the glucose infusion rate curve (only for biphasic insulin aspart 30)(from 0 to 24 hours after single-dose administration)
研究者
研究点 (1)
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