A Randomized, 2X4 Week, Active-Controlled, Open-Label, 2-Treatment Arm, 2-Period Cross-Over Study Assessing the Safety of SAR342434 and Humalog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Frequency of infusion set occlusions
研究概览
简要总结
Primary Objective:
- Assess the safety of SAR342434 and Humalog when used in external pumps.
Secondary Objectives:
- Intervals for infusion set changes.
- Incidence of insulin pump alarms for infusion set occlusion.
- Patient observation of infusion set occlusion.
- Adverse events including bruising at the infusion site and injection site reactions.
详细描述
The study duration for each patient will be approximately 10 weeks.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（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
SAR342434/Humalog
SAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
干预措施: SAR342434 (Drug)
SAR342434/Humalog
SAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
干预措施: insulin lispro (Drug)
Humalog/SAR342434
Humalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
干预措施: SAR342434 (Drug)
Humalog/SAR342434
Humalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
干预措施: insulin lispro (Drug)
结局指标
主要结局
Frequency of infusion set occlusions
时间窗: 4 weeks
次要结局
- Number of infusion set changes in each treatment period(4 weeks)
- Number of adverse events(4 weeks)
- Number of insulin pump alarms for infusion set occlusions(4 weeks)