A Euglycaemic Clamp Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of a Bolus Dose of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® by an Insulin Pump
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- AUCGIR(0-60min)
研究概览
简要总结
This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight.
Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes Mellitus for more than 12 months.
- •BMI between 18.5 and 28.5 kg/m².
- •HbA1C level <=9.0%.
- •Insulin treated for at least 12 months with total insulin dose <1.2U/kg/day.
排除标准
- •Type 2 Diabetes Mellitus.
- •History of multiple and/or severe allergies to drugs or foods.
- •Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
- •More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
- •Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
- •Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.
研究组 & 干预措施
BioChaperone® insulin lispro
Single subcutaneous administration of BioChaperone® insulin lispro
干预措施: BioChaperone® insulin lispro (Drug)
Fiasp®
Single subcutaneous administration of Fiasp® (insulin aspart)
干预措施: Fiasp® (Drug)
Novorapid®
Single subcutaneous administration of Novorapid® (insulin aspart)
干预措施: Novorapid® (Drug)
结局指标
主要结局
AUCGIR(0-60min)
时间窗: 60 minutes
Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration
次要结局
- AUCins(0-60min)(60 minutes)
- GIRmax(10 hours)
- Adverse Events(up to 8 weeks)
- AUCins(0-30min)(30 minutes)
- AUCins(0-600min)(600 minutes)
- Cmax insulin(10 hours)
- TmaxGIR(10 hours)
- Clinical safety laboratory(up to 8 weeks)
- Tmax insulin(10 hours)