NCT01076634已完成1 期
A Trial Investigating the Pharmacodynamic Properties of NN1250 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
- 试验地点
- 1
- 主要终点
- Area under the glucose infusion rate curve during one dosing interval at steady-date"
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations 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 65 Years（Adult, Older 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period
研究组 & 干预措施
IDeg 100 U/mL
Experimental
干预措施: insulin degludec (Drug)
IDeg 200 U/mL
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve during one dosing interval at steady-date"
时间窗: After 8 days of treatment
次要结局
- Area under the serum Insulin Degludec concentration-time curve(From 0 to 24 hours after single dose)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01467414Novo Nordisk A/S1
已完成
1 期
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01618188Novo Nordisk A/S52
已完成
1 期
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01590836Novo Nordisk A/S22
已完成
1 期
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01773798Novo Nordisk A/S33
已完成
1 期
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT02033239Novo Nordisk A/S46