A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Glucodynamic endpoint: Area Under the Curve GIR(0-last)
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 facilitation of the absorption of the insulin after subcutaneous injection.
The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.
This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus.
Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 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
- 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
- •Type 1 diabetes mellitus for at least 12 months
- •Treated with multiple daily insulin injections of insulin pump for at least 12 months
- •Body Mass Index (BMI): 18.5-28.0 Kg.m²
排除标准
- •Type 2 diabetes mellitus
- •Receipt of any investigational product within 3 months prior 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 1 year prior to screening
- •Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
研究组 & 干预措施
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
干预措施: BioChaperone insulin lispro 0.2U/Kg (Drug)
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
干预措施: BioChaperone insulin lispro 0.1U/Kg (Drug)
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
干预措施: BioChaperone insulin lispro 0.4U/Kg (Drug)
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
干预措施: Humalog® (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
干预措施: BioChaperone insulin lispro 0.2U/Kg (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
干预措施: BioChaperone insulin lispro 0.1U/Kg (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
干预措施: BioChaperone insulin lispro 0.4U/Kg (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
干预措施: Humalog® (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
干预措施: BioChaperone insulin lispro 0.2U/Kg (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
干预措施: BioChaperone insulin lispro 0.1U/Kg (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
干预措施: BioChaperone insulin lispro 0.4U/Kg (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
干预措施: Humalog® (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
干预措施: BioChaperone insulin lispro 0.2U/Kg (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
干预措施: BioChaperone insulin lispro 0.1U/Kg (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
干预措施: BioChaperone insulin lispro 0.4U/Kg (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
干预措施: Humalog® (Drug)
结局指标
主要结局
Glucodynamic endpoint: Area Under the Curve GIR(0-last)
时间窗: 12 hours
Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp
Glucodynamic endpoint: GIRMax
时间窗: 12 hours
Maximum Glucose Infusion Rate
Pharmacokinetic endpoint: AUC Lisp(0-last)
时间窗: 12 hours
Area under the insulin lispro serum concentration - time curve over the clamp procedure.
Pharmacokinetic endpoint: Cmax(Lisp)
时间窗: 12 hours
Maximum observed serum insulin lispro concentration
次要结局
- Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.(12 weeks)
- Pharmacokinetics: Tmax(lisp)(12 hours)
- Glucodynamic: TGIRmax(12 hours)
- Tonset of action(12 hours)