Safety Assessment of SAR341402 and NovoLog® 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
- 45
- 试验地点
- 3
- 主要终点
- Infusion set occlusions
研究概览
简要总结
Primary Objective:
- To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions.
Secondary Objectives:
- To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of unexplained hyperglycemia.
- To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of:
- Intervals for infusion set changes.
- Number of patients with insulin pump for "non-delivery" alarm.
- Patient observation of infusion set occlusion.
- Adverse events and serious adverse events.
- Number of patients with hypoglycemic events [according to ADA (American Diabetes Association) Workgroup on hypoglycemia].
详细描述
The study duration for each patient will be approximately 10 weeks, including a 2-week screening period, 2 treatment periods of 4 weeks each, and 1-day post-treatment safety follow-up period.
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
- 18 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
SAR341402/NovoLog
SAR341402 will be self-administered via continuous subcutaneous insulin infusion via an insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. After 4 weeks of SAR341402 as treatment, patient will switch with NovoLog® as treatment.
干预措施: Insulin aspart SAR341402 (Drug)
NovoLog/SAR341402
Novolog will be self-administered via continuous subcutaneous insulin infusion via an insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. After 4 weeks of NovoLog® as treatment, patient will switch with SAR341402 as treatment.
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Infusion set occlusions
时间窗: At week 4 from baseline of each treatment
Number of patients with infusion set occlusions. Infusions set occlusions are defined as infusion set change due to failure to correct hyperglycemia (plasma glucose ≥ 250 mg/dL \[13.9 mmol/L\]) by insulin bolus via the insulin pump.
次要结局
- Intervals for infusion set changes(At week 4 from baseline of each treatment)
- Patient observation of infusion set occlusion(Up to 10 weeks)
- Unexplained hyperglycemia(At week 4 from baseline of each treatment)
- Number of patients with hypoglycemic events(At week 4 from baseline of each treatment)
- Number of patients with insulin pump alarms for "non-delivery"(At week 4 from baseline of each treatment)
- Adverse events and serious adverse events(Up to 10 weeks)