NCT01349855已完成1 期
A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Assess the Safety and Tolerability of Two Dose Levels of a New Formulation of Insulin Glargine and to Compare Its Pharmacodynamic and Pharmacokinetic Properties With 0.4 U/kg/Day Lantus® in an 8-days Multiple Dosing Regimen in Patients With Diabetes Mellitus Type 1
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen
Secondary Objective:
To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen
详细描述
The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.
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 65 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
研究组 & 干预措施
Cohort 1
Experimental
Dose Level 1
干预措施: Insulin glargine HOE901 (Drug)
Cohort 2
Experimental
Dose Level 2
干预措施: Insulin glargine HOE901 (Drug)
结局指标
主要结局
Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory
时间窗: up to day 10 of each period
次要结局
- Glucose infusion rate(up to day 10 of each period)
- Pharmacokinetic parameter : Cmax(up to day 10 of each period)
- Pharmacokinetic parameter : Tmax(up to day 10 of each period)
- Pharmacokinetic parameter : AUC(up to day 10 of each period)
研究者
研究点 (1)
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