A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 37
- 主要终点
- Area under the curve (AUC)
研究概览
简要总结
The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection.
The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg.
This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.
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
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus for at least 12 months.
- •Treated with multiple daily insulin injections or insulin pump for at least 12 months.
- •Body Mass Index (BMI): 18.0-28.0 Kg/m².
排除标准
- •Type 2 diabetes mellitus.
- •Receipt of any investigational product within 3 months prior to first dosing.
- •Clinically significant abnormalities as judged by the investigator.
- •Any systemic treatment with drugs known to interfere with glucose metabolism.
- •History of alcoholism, or drug/chemical abuse as per Investigator's judgement.
- •Use of tobacco or nicotine-contained product within 5 years prior to screening.
- •Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.
研究组 & 干预措施
BioChaperone insulin lispro
BioChaperone insulin lispro
干预措施: BioChaperone insulin lispro (Drug)
Humalog®
Humalog®
干预措施: Humalog® (Drug)
结局指标
主要结局
Area under the curve (AUC)
时间窗: 30 minutes
Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes
次要结局
- Pharmacokinetics: Early t0.5max(Lisp)(up to 6 hours post administration of study drug)
- Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours(6 hours)
- Glucodynamics: Early t0.5(GIRmax)(6 hours)
- Glucodynamic: GIRmax (Maximum glucose infusion rate)(6 hours)
- Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours(6 hours)
- Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration(6 hours)
- Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters(8 weeks)