An Open-label, 2 Replicate Single Dose Euglycemic Glucose-Clamp Trial to Characterize PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Assessment of PK parameter: area under the serum insulin concentration time curve from time 0 to 8H (INS-AUC0-8H)
研究概览
简要总结
Primary Objective:
To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting.
To characterize the within-subject variability in the metabolic activity (pharmacodynamic [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting.
Secondary Objectives:
To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.
To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.
To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.
详细描述
The maximum study duration per patient is approximately 9 weeks (screening of 3 to 28 Days, treatment period of 2 days [Periods 1 and 2], washout period of 5 to 19 days [between treatment period], and end-of-study visit of 7 to 14 days after study drug administration in Period 2).
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
- 18 Years 至 65 Years（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
Afrezza®
Two-period, replicate single dose, euglycemic clamp study. There will be 2 treatment periods with a replicate administration of 1 dose of Afrezza TI (40U) in both periods.
Each patient will be given a replicate administration of 1 dose level of Afrezza TI with washout duration between treatment periods (5-19 days between periods, ie, 7 to 21 days between dosing occasions).
干预措施: Technosphere Insulin SAR439065 Afrezza® (Drug)
结局指标
主要结局
Assessment of PK parameter: area under the serum insulin concentration time curve from time 0 to 8H (INS-AUC0-8H)
时间窗: 8 hours
Assessment of PD parameter: area under the glucose infusion rate curve (GIR) necessary to maintain euglycemia during the euglycemic clamp over 8 hours
时间窗: 8 hours
次要结局
- Assessment of PK parameter: maximum Afrezza insulin serum concentration (INS-Cmax)(8 hours)
- Assessment of PK parameter: time to INS-Cmax (INS-tmax)(8 hours)
- Assessment of PD parameter: maximum smoothed GIR (GIRmax)(8 hours)
- Assessment of PD parameter: time to GIRmax (GIR-Tmax)(8 hours)