A Randomized, Double-blind, Single-dose, Cross-over Study in Two Cohorts to Compare Exposure and Activity of SAR341402 Mix 70/30 to Novolog® Mix 70/30, Novomix® 30 and SAR341402 Rapid-Acting Solution Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- (Cohort 2) Assessment of PK parameters: Area under the insulin concentration time curve from 0 to 4 hours post administration (INS-AUC0-4H)
研究概览
简要总结
Primary Objectives:
- To demonstrate similarity in exposure of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and NovoMix 30 (cohort 1).
- To demonstrate distinctiveness in early and intermediate exposure of SAR341402 Mix 70/30 compared to SAR341402 rapid-acting solution (cohort 2).
Secondary Objectives:
- To demonstrate similarity in activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and NovoMix 30.
- To demonstrate distinctiveness in early and intermediate activity of SAR341402 Mix 70/30 compared to SAR341402 rapid-acting solution.
- To assess the safety and tolerability of SAR341402 rapid-acting solution and SAR341402 Mix 70/30.
详细描述
- Cohort 1: The total study duration for a screened patient will be about 3 - 8 weeks (excluding screening), with screening period of 4 to 28 days, 3 treatment periods of 2 days each period, washout period of 5 to 18 days, and end-of-study visit at 5 to 12 days after last IMP administration.
- Cohort 2: The total study duration for a screened patient will be about 2 - 5 weeks (excluding screening), with screening period of 4 to 28 days, 2 treatment periods of 2 days each period, washout period of 5 to 18 days, and end-of-study visit at 5 to 12 days after last IMP administration.
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 64 Years（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
Test (T)
SAR341402 Mix 70/30: single dose injection
干预措施: SAR341402 (Drug)
Reference 1 (R1)
NovoLog Mix 70/30: single dose injection
干预措施: Insulin Aspart (Drug)
Reference 2 (R2)
NovoMix30: single dose injection
干预措施: Insulin Aspart (Drug)
Reference 3 (R3)
SAR341402 rapid-acting solution: single dose injection
干预措施: SAR341402 (Drug)
结局指标
主要结局
(Cohort 2) Assessment of PK parameters: Area under the insulin concentration time curve from 0 to 4 hours post administration (INS-AUC0-4H)
时间窗: 0 to 4 hours
INS-AUC0-4H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 0 to 4 hours
(Cohort 2) Assessment of PK parameter: Maximum insulin concentration (INS-Cmax)
时间窗: 24 hours
(Cohort 2) Maximum plasma concentration (Cmax) of SAR341402 Mix 70/30 and SAR341402 rapid acting solution within 24 hours
(Cohort 1) Assessment of PK parameter: Maximum insulin concentration (INS-Cmax)
时间窗: 24 hours
Maximum plasma concentration (Cmax) of SAR341402 Mix 70/30, NovoLog Mix 70/30, NovoMix 30 and SAR341402 within 24 hours
(Cohort 1) Assessment of PK parameter: Area under the insulin concentration time curve (INS-AUClast)
时间窗: 0 to 24 hours
INS-AUC of SAR341402 Mix 70/30, NovoLog Mix 70/30, and NovoMix 30 from 0 to 24 hours
(Cohort 2) Area under the insulin concentration time curve from 4 to 12 hours post administration (INS-AUC4-12H)
时间窗: 4 to 12 hours
INS-AUC4-12H for SAR341402 Mix 70/30 and SAR341402 rapid acting solution from 4 to 12 hours
次要结局
- Assessment of PK parameter: Time to Cmax (INS-tmax)(24 hours)
- Assessment of PD parameter: The area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 4 hours post administration (GIR-AUC0-4H)(0 to 4 hours)
- Assessment of PD parameter: The area under the body weight standardized glucose infusion rate (GIR) versus time curve from 4 to 12 hours post administration (GIR-AUC4-12H)(4 to 12 hours)
- Assessment of PK parameter: Area under the insulin concentration time curve from 0 to infinity (INS-AUC)(0 to 24 hours)
- Assessment of PK parameter: Area under the insulin concentration time curve for fractional periods post administration (INS-AUC0-4H, INS-AUC0-24H, INS-AUC4-24H)(0 to 4 hours, 0 to 24 hours, and 4 to 24 hours)
- Assessment of PK parameter: Time to INS-Cmax(24 hours - 4. 24 hours - 5. 0 to 24 hours - 6. 24 hours - 7. 24 hours - 8. 24 hours - 9. 0 to 4 hours - 10. 4 to 12 hours - 11. 24 hours - 12. 24 hours -)
- Assessment of PK parameter: Half-life (t1/2)(24 hours)
- Assessment of PD parameter: GIR versus time curve from 0 to 24 hours post administration (GIR-AUC0-24H)(0 to 24 hours)
- Assessment of PD parameter: Maximum smoothed body weight standardized glucose infusion rate (GIRmax)(24 hours)
- Assessment of PD parameter: Time to GIRmax (GIR-tmax)(24 hours)