临床试验/NCT01590836

NCT01590836已完成1 期

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 22 人开始时间: 2012年4月最近更新: 2017年2月10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: 22
试验地点: 1
主要终点: Area under the glucose infusion rate curve during one dosing interval

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研究点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 aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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
•Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
•Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)
•Glycosylated haemoglobin (HbA1c) maximum 9.5 %
•Fasting C-peptide maximum 0.3 nmol/L

排除标准

•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, use of nicotine gum or transdermal nicotine patches during the inpatient period
•Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
•Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

研究组 & 干预措施

IDeg-->IDegAsp

Experimental

干预措施: insulin degludec (Drug)

IDeg-->IDegAsp

Experimental

干预措施: insulin degludec/insulin aspart (Drug)

结局指标

主要结局

Area under the glucose infusion rate curve during one dosing interval

时间窗: At steady state (0-24 hours)

次要结局

Maximum glucose infusion rate (GIRmax)(At steady state (within 0-24 hours after last dosing))
Maximum observed serum insulin degludec concentration(At steady state (within 0-24 hours after last dosing))
Area under the serum insulin degludec concentration-time curve during one dosing interval(At steady state (within 0-24 hours after last dosing))
Area under the serum insulin aspart concentration-time curve(From 0 to 12 hours)
Maximum observed serum insulin aspart concentration(Within 0-12 hours after dosing of IDegAsp)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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