A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Paediatric (10 - 17 Years Old) and Adult Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value
研究概览
简要总结
Primary Objective:
- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls
Secondary Objectives:
- To evaluate in both paediatric and adult populations:
- the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses
- the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast
- safety and tolerability.
详细描述
The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose 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
- 10 Years 至 65 Years（Child, 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
Placebo
1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously
干预措施: Placebo (Drug)
Dose 1
1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously
干预措施: Lixisenatide (AVE0010) (Drug)
Dose 2
1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously
干预措施: Lixisenatide (AVE0010) (Drug)
结局指标
主要结局
GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value
时间窗: D1 at each period up to 4h30 after study drug injection (8 timepoints)
次要结局
- Pharmacokinetics: lixisenatide plasma concentration(0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints))
- Pharmacokinetic parameter (Cmax)(calculated over the period of timepoints at D1 of each study period)
- Pharmacokinetic parameter (Tmax)(calculated over the period of timepoints at D1 of each study period)
- Pharmacokinetic parameter (AUC last)(estimated over the period of timepoints at D1 of each study period)
- Pharmacokinetic parameter (AUC)(extrapolated based on the period of timepoints at D1 of each study period)
- Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon(D1 at each period up to 4h30 after study drug injection (7 timepoints))