临床试验/NCT01497561

NCT01497561已完成1 期

A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 Diabetes

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2003年3月最近更新: 2017年1月27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: 15
试验地点: 1
主要终点: Area under the glucose infusion rate 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 pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes
•Subjects treated with insulin for minimum 3 months
•Duration of diabetes for at least 12 months
•Body Mass Index (BMI) below 30 kg/m^2
•HbA1c maximum 10% based on analysis from central laboratory

排除标准

•Current treatment with insulin above 1.2 U/kg/day
•Current treatment with insulin glargine
•Current treatment with drugs known to interfere with glucose metabolism
•Current treatment with oral antidiabetic drugs

研究组 & 干预措施

insulin detemir

Experimental

干预措施: insulin detemir (Drug)

insulin NPH

Active Comparator

干预措施: insulin NPH (Drug)

结局指标

主要结局

Area under the glucose infusion rate curve

次要结局

Area under the curve
Maximum glucose infusion rate
Maximum concentration
Time to maximum concentration
Insulin clearance
Mean residence time of insulin
Terminal rate constant
Terminal half-life
Time to maximum glucose

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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