Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses 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
- 46
- 试验地点
- 1
- 主要终点
- - Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
研究概览
简要总结
Primary Objective:
- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.
Secondary Objective:
- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM
详细描述
The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:
- Screening: 3 to 27 days;
- Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;
- Wash-out between doses: 7 to 10 days;
- End of Study visit: 7 to 10 days after last dose.
- Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.
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 60 Years（Adult）
- 性别
- Male
- 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
Cohort 1 : SAR161271 0.3 U/kg
Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
干预措施: SAR161271 (Drug)
Cohort 1 : SAR161271 0.3 U/kg
Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
干预措施: Insulin glargine HOE901 (Drug)
Cohort 2 : SAR161271 0.6 U/kg
Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
干预措施: SAR161271 (Drug)
Cohort 2 : SAR161271 0.6 U/kg
Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
干预措施: Insulin glargine HOE901 (Drug)
Cohort 3 : SAR161271 1.2 U/kg
Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
干预措施: SAR161271 (Drug)
Cohort 3 : SAR161271 1.2 U/kg
Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
干预措施: Insulin glargine HOE901 (Drug)
结局指标
主要结局
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
时间窗: up to 7 days after dose
- Pharmacodynamics (Glucose infusion rate) time-action profile
时间窗: up to 30 hours after dose
次要结局
- - Pharmacokinetic parameters(up to 168 hours after dose)
- - anti-insulin antibody production(pre-dose and after 4th dose)