NCT01051102已完成1 期
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese 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
- 21
- 试验地点
- 1
- 主要终点
- Area under the Glucose Infusion Rate curve after a single dose
研究概览
简要总结
This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese subject
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index (BMI): 18.0-28.0 kg/m^2 (both inclusive)
排除标准
- •Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
- •Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) 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
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
BIAsp 30
Active Comparator
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Area under the Glucose Infusion Rate curve after a single dose
时间窗: From 4-12 hours
次要结局
- Area under the insulin aspart concentration-time curve after a single dose(From 0-12 hours)
研究者
研究点 (1)
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