临床试验/NCT01469143

NCT01469143已完成1 期

A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

Novo Nordisk A/S0 个研究点目标入组 40 人开始时间: 2011年11月最近更新: 2015年2月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 40
主要终点: Area under the serum insulin aspart concentration-time curve

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.

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 64 Years（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/m^2 (both inclusive)

排除标准

•Subjects 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

Experimental

干预措施: Faster-acting insulin aspart (Drug)

insulin aspart

Active Comparator

干预措施: insulin aspart (Drug)

结局指标

主要结局

Area under the serum insulin aspart concentration-time curve

时间窗: From 0 to 1 hour

次要结局

Area under the serum insulin aspart concentration-time curve(From 0 to 12 hours)
Maximum observed serum insulin aspart concentration(From 0 to 12 hours)
Time to maximum observed serum insulin aspart concentration(From 0 to 12 hours)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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