Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
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 blood glucose time curve: AUCbg(0-2h)
研究概览
简要总结
The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.
This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.
This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
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
- Triple (Participant, Care Provider, Investigator)
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 ≥ 12 months
- •Treated with multiple daily insulin injections or CSII ≥ 12 months
- •BMI 18.5-28.0 kg/m² (both inclusive)
- •HbA1C%≤9%
排除标准
- •Type 2 Diabetes Mellitus
- •Receipt of any trial product within 60 days prior to this trial
- •Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
- •Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
- •Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
- •Any systemic treatment with drugs known to interfere with glucose metabolism
- •Use of any tobacco or nicotine-contained product within one year prior to screening
研究组 & 干预措施
Biochaperone Insulin Lispro
干预措施: BioChaperone insulin lispro (Drug)
Humalog®
干预措施: Humalog® (Drug)
结局指标
主要结局
Area under the blood glucose time curve: AUCbg(0-2h)
时间窗: 2 hours
Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal
次要结局
- Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax(8 hours)
- Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters(Up to 7 weeks)
- Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)(8 hours)
- Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)(8 hours)
- Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)(8 hours)