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.
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
- 否
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
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