NCT02527265已完成2 期
Open-label, Single-arm, Multiple-dose Safety, Titration, and Pharmacokinetic Trial of Afrezza® in Pediatric Patients Ages 4 to 17 Years With Type 1 Diabetes Mellitus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 26
- 主要终点
- Insulin Maximum Observed Concentration (Cmax)
研究概览
简要总结
Primary Objective:
-To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM).
Secondary Objectives:
- To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal.
- To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM.
详细描述
The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 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
结局指标
主要结局
Insulin Maximum Observed Concentration (Cmax)
时间窗: 250 minutes post-dose
Insulin Cmax after a dose of Afrezza
次要结局
- Insulin Time to Reach Cmax (Tmax)(250 minutes post-dose)
- Insulin Area Under Concentration Time Curve (AUC)(250 minutes post-dose)
- Assessment of Fumaryl Diketopiperazine (FDKP) Elimination Half-life (t1/2)(Using PK data collected over 250 minutes post-dose of Afrezza)
研究者
研究点 (26)
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