Phase I Single Dose, Randomised, Double-blind, Three-way Cross Over, Glucose Clamp Study Investigating the PK/PD and Safety of Arecor Ultra-rapid Insulin Aspart (AT247) in Comparison to NovoRapid® and Fiasp® in Participants With Type I Diabetes Mellitus (T1DM).

Arecor Limited2 个研究点分布在 1 个国家目标入组 18 人开始时间: 2019年4月12日最近更新: 2019年9月30日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 18
试验地点: 2
主要终点: Area under the glucose infusion rate-time curve of insulin aspart

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.

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: Male
接受健康志愿者: 否

入选标准

•Diagnosis type I Diabetes Mellitus for at least 12 months
•Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
•Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
•BMI 18.5-35.0 kg/m2

排除标准

•known or suspected hypersensitivity to Investigational Medicinal Products
•clinically significant concomitant disease or abnormal lab values
•supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg