A Randomized, Double-blind, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro 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
- 90
- 试验地点
- 1
- 主要终点
- Assessment of pharmacokinetc (PK) parameter:INS-Cmax
研究概览
简要总结
Primary Objective:
To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose
Secondary Objectives:
- To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
- To assess the safety and tolerability of the test and the reference formulation of insulin lispro
详细描述
Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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)
Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period
干预措施: Insulin Lispro SAR342434 (Drug)
Reference (R)
Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period
干预措施: Insulin Lispro SAR342434 (Drug)
结局指标
主要结局
Assessment of pharmacokinetc (PK) parameter:INS-Cmax
时间窗: 10 hours
Maximum Insulin (INS) concentration
Assessment of PK parameter :INS-AUClast -
时间窗: 10 hours
Area under INS concentration time curve from 0 to last measurable concentration -
次要结局
- Assessment of PK parameter:INS-t1/2z(10 hours)
- Adverse Events(Up to Day 62)
- Assessment of PD parameter:GIR-max(8 hours)
- Assessment of PK parameter:INS-tmax(10 hours)
- Assessment of PK parameter:INS-AUC(10 hours)
- Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8(8 hours)
- Assessment of PD parameter:GIR-tmax(8 hours)
- Duration of blood glucose control(8 hours)