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临床试验/NCT00566124
NCT00566124已完成4 期

No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans

University of Aarhus1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.

研究概览

简要总结

To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.

详细描述

In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • BMI 20 - 50 kg/m2
  • Blood pressure < 140/90 mmHg
  • signed informed consent
  • Caucasien

排除标准

  • Diabetes or other disease
  • Alcohol or drug abuse
  • Use of prescription drugs

研究组 & 干预措施

1

Active Comparator

Insulin detemir

干预措施: Insulin detemir (Drug)

2

Active Comparator

Insulin glargine

干预措施: Insulin glargine (Drug)

3

Active Comparator

NPH insulin

干预措施: Insulatard (Drug)

结局指标

主要结局

Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.

时间窗: 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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