NCT00964418已完成1 期
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric 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
- 27
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250)
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly 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 65 Years（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)
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
IDeg
Experimental
干预措施: insulin degludec (Drug)
IGlar
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250)
时间窗: 0-24 hours (derived on treatment day 6)
次要结局
- Area under the NN1250 concentration-time curve during one dosing interval at steady state(0-24 hours (derived on treatment day 6))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Trial Investigating the Effect of NN5401 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01134224Novo Nordisk A/S39
已完成
1 期
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 DiabeticsDiabetesDiabetes Mellitus, Type 1NCT00992537Novo Nordisk A/S27
已完成
1 期
A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01154881Novo Nordisk A/S49
已完成
1 期
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01173926Novo Nordisk A/S27
已完成
1 期
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01924637Novo Nordisk A/S36