试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Sanofi
- 主要终点
- Time to reach a smoothed blood glucose of 70 mg/dL after initial administration of investigational medicinal product
研究概览
简要总结
Primary Objective:
To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544 versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia.
Secondary Objective:
To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia.
详细描述
The total duration of study per patient is up to 8 weeks with 3 to 28 days screening period, 1 day for treatment for both periods and 7 to 14 days wash out between 2 administrations, and 7 days (+/- 1 day) follow-up 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
- Basic Science
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 60 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
SAR438544 dose 1
Single dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
干预措施: SAR438544 (Drug)
SAR438544 dose 1
Single dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
干预措施: insulin (Drug)
Glucagon
Single dose of glucagon given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
干预措施: r-glucagon (Drug)
Glucagon
Single dose of glucagon given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
干预措施: insulin (Drug)
SAR438544 Optional Dose
Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
干预措施: SAR438544 (Drug)
SAR438544 Optional Dose
Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
干预措施: insulin (Drug)
结局指标
主要结局
Time to reach a smoothed blood glucose of 70 mg/dL after initial administration of investigational medicinal product
时间窗: Day 1
次要结局
- Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): tmax(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): tlast(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half-life(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): area under curve from zero time until the last measurable concentration (AUClast)(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): AUC(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): partial AUCs (AUC0-t)(Day 1)
- Number of patients with adverse events(Day 1 to Day 7 (+/- 1 day))
- Time to reach a smoothed blood glucose of 90 mg/dL after initial administration of investigational medicinal product(Day 1)
- Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose(Day 1)
- Assessment of PD parameter: area under plasma concentration of the BG-time curve between IMP dosing and time t (BG-AUC0-t)(Day 1)
- Assessment of PD parameter: BG-maximum concentration (BG-Cmax)(Day 1)
- Assessment of PD parameter: BG-time to Cmax (BG-tmax)(Day 1)