Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 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
- 21
- 主要终点
- End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)
研究概览
简要总结
BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.
The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.
This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two 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 (or equal to ) 12 months,
- •Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
- •Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)
排除标准
- •Type 2 diabetes mellitus,
- •The receipt of any investigational product within 3 month 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 and any tobacco product within 5 years 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
B
Drug: Humalog® Mix25
干预措施: Humalog® Mix25 (Drug)
A
Drug: BioChaperone® Combo
干预措施: BioChaperone® Combo (Drug)
结局指标
主要结局
End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)
时间窗: from 0 to 30 hours after a single-dose administration
次要结局
- Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25(from 0 to 30 hours after a single-dose administration)
- Number of Adverse Events(Weeks 0-10)