临床试验/NCT01707160

NCT01707160已完成1 期

A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 24 人开始时间: 1995年11月最近更新: 2017年1月4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: 24
试验地点: 1
主要终点: Area under the 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 pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

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 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Non-smokers
•BMI (body mass index) maximum 27 kg/m^2
•HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
•FBG (fasting blood glucose) maximum 6.0 mmol/L

排除标准

未提供

研究组 & 干预措施

Treatment period 1

Experimental

干预措施: biphasic insulin aspart 30 (Drug)

Treatment period 1

Experimental

干预措施: biphasic human insulin 30 (Drug)

Treatment period 2

Active Comparator

干预措施: biphasic insulin aspart 30 (Drug)

Treatment period 2

Active Comparator

干预措施: biphasic human insulin 30 (Drug)

结局指标

主要结局

Area under the Curve

次要结局

Maximum insulin concentration (Cmax)
Time to maximum insulin concentration (tmax)
Adverse events
Minimum glucose concentration (Cmin(glu))
Time to minimum glucose concentration (tmin(glu))

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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