A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) 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
- 38
- 试验地点
- 1
- 主要终点
- Area under the curve (AUCins(0-1h))
研究概览
简要总结
The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.
The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.
This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 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
- •Male subject with type 1 diabetes for at least 12 months
- •Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
- •Body mass index: 18.5-28.0 kg BW·m-2
- •HbA1c: ≤ 9.0%
排除标准
- •Diabetes mellitus type 2
- •Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
- •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 any tobacco or nicotine-contained product within one year prior to screening
研究组 & 干预措施
Human insulin
Huminsulin® Normal
干预措施: BioChaperone human insulin (Drug)
BioChaperone human insulin
BioChaperone Human Insulin
干预措施: BioChaperone human insulin (Drug)
BioChaperone human insulin
BioChaperone Human Insulin
干预措施: Huminsulin® Normal (Drug)
BioChaperone human insulin
BioChaperone Human Insulin
干预措施: Humalog® (Drug)
Insulin lispro
Humalog®
干预措施: Humalog® (Drug)
Human insulin
Huminsulin® Normal
干预措施: Huminsulin® Normal (Drug)
Human insulin
Huminsulin® Normal
干预措施: Humalog® (Drug)
Insulin lispro
Humalog®
干预措施: BioChaperone human insulin (Drug)
Insulin lispro
Humalog®
干预措施: Huminsulin® Normal (Drug)
结局指标
主要结局
Area under the curve (AUCins(0-1h))
时间窗: 1 hour
Area under the human insulin serum concentration - time curve from t=0 to 1 hour
次要结局
- Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters(up to 7 weeks)
- Pharmacokinetics: Cmax(ins/lisp)(up to 10 hours)
- Pharmacokinetics: Early t0.5max ins/lisp(up to 10 hours post administration)
- Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours(10 hours)
- Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)(10 hours)
- Glucodynamics: GIRmax - Maximum glucose infusion rate(10 hours)
- Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration(10 hours)
- Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration(10 hours)
- Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours(2 hours post administration)