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临床试验/NCT00297583
NCT00297583已完成1 期

A Single-center, Randomized, Double-blind, 3-period Cross-over Trial to Compare the Effect of Insulin Glulisine, Insulin Lispro and Unmodified Human Insulin on the Endogenous Glucose Production in Type 1 Diabetic Patients.

Sanofi0 个研究点开始时间: 2004年4月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Sanofi
主要终点
serum insulin concentrations

研究概览

简要总结

The primary objective of the study was to compare the effect of insulin glulisine, insulin lispro and unmodified human insulin on endogenous glucose production during euglycemic glucose clamps using stable labeled glucose in type 1 diabetic subjects.

The secondary objectives of the study were to assess:

  • the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma nonesterified free fatty acids (NEFA) and glycerol levels
  • the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma lactate levels
  • the safety and tolerability of insulin glulisine in comparison to insulin lispro and unmodified human insulin.

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

serum insulin concentrations

时间窗: During the Study Conduct

次要结局

  • glucose infusion rates(During the study conduct)
  • blood glucose concentrations(During the study conduct)
  • Adverse events and hypoglycemic episodes collection(from the inform consnet signed up to the end of the study)

研究者

发起方
Sanofi
申办方类型
Industry

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