NCT01121289已完成1 期
A Trial Investigating the Pharmacokinetic Properties of NN1218 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
- 26
- 主要终点
- Area under the serum NN1218 concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 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 for more than 12 months
- •Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
- •Body mass index (BMI) between 18.0-28.0 kg/m2 (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 trial start
- •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
NN1218, formulation A
Experimental
干预措施: NN1218 (Drug)
NN1218, formulation B
Experimental
干预措施: NN1218 (Drug)
NN1218, formulation B (high)
Experimental
干预措施: NN1218 (Drug)
NN1218, formulation C
Experimental
干预措施: NN1218 (Drug)
NN1218, formulation D
Experimental
干预措施: NN1218 (Drug)
insulin aspart
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the serum NN1218 concentration-time curve
时间窗: From 0-1 hours
次要结局
- Area under the serum NN1218 concentration-time curve(From 0-10 hours)
研究者
相似试验
已完成
1 期
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT02035371Novo Nordisk A/S41
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
已完成
1 期
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT02003677Novo Nordisk A/S67
已完成
1 期
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy SubjectsHealthyDiabetesNCT01931137Novo Nordisk A/S45
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