A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects 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
- 30
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog
研究概览
简要总结
Primary Objective:
To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.
Secondary Objective:
To assess the safety and tolerability of SAR342434.
详细描述
The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)
- Screening: 2 to 28 days (D -28 to D -2)
- Treatment period 1 - 3: 2 days (1 overnight stay)
- Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
- End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.
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
Test (T)
SAR342434: single dose injection
干预措施: SAR342434 (Drug)
Reference 1 (R1)
US-approved Humalog®: single dose injection
干预措施: Insulin Lispro (Drug)
Reference 2 (R2)
EU-approved Humalog®: single dose injection
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog
时间窗: 12 hours
Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)
时间窗: 12 hours
Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog
时间窗: 12 hours
次要结局
- Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)(12 hours)
- The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)(12 hours)
- Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia(8 weeks)
- Time to 20% of AUC (t20%-AUC)(12 hours)
- Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)(12 hours)
- The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)(12 hours)
- NS-tmax, INS-t1/2z(12 hours)
- Maximum smoothed body weight standardized GIR (GIRmax)(12 hours)
- Time to GIRmax (GIR-tmax)(12 hours)