A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pharmacodynamics: ΔAUCBG 0-2h
研究概览
简要总结
This study is constituted of 2 parts:
Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including:
- Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the post-prandial glucose response for 6 hours after individualized standard meal (fixed nutrient ratio) ingestion and bolus administration via CSII.
- Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode (i.e. neither subjects nor the investigators are aware of the sensor glucose values).
- Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the Investigational Medicinal Products (IMP) during the outpatient periods.
Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed.
Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe.
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 for at least 12 months
- •Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
- •Using or having used a Roche CSII system (Accu-Chek® Spirit Combo/ Accu- Chek® Spirit) for at least 6 months before screening. In Part B subjects using any form of CSII treatment for at least 6 months before screening will be included.
- •HbA1c <= 9.0%.
- •Total insulin dose of < 1.2 (I)U/kg/day
- •Ability to calculate insulin bolus manually or using a bolus calculator and willingness to consume regular meals, perform carbohydrate counting, self-monitoring of plasma glucose (SMPG) profiles and use of Continuous Glucose Monitoring (CGM).
- •Fasting C-peptide <= 0.30 nmol/L
排除标准
- •Known or suspected hypersensitivity to Investigational Medicinal Product(s) (IMP(s)) or related products
- •Type 2 diabetes mellitus
- •Previous participation in this trial.
- •Receipt of any investigational product in a clinical trial within 60 days before randomisation in this trial
- •Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening test
- •Presence of clinically significant acute gastrointestinal symptoms
- •Known slowing of gastric emptying and or gastrointestinal surgery
- •Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the trial
- •History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening
- •History of abscess at the infusion site within 6 months prior to screening
- •Hypoglycaemia unawareness as judged by the Investigator
- •History of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening
研究组 & 干预措施
BioChaperone insulin lispro
干预措施: BioChaperone insulin lispro (Drug)
Humalog®
Insulin lispro
干预措施: Humalog® (Drug)
结局指标
主要结局
Pharmacodynamics: ΔAUCBG 0-2h
时间窗: 2 Hours
Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.
Pharmacokinetics: AUClis 0-30min
时间窗: 30 minutes
Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes
次要结局
- tCmax(up to 6 Hours)
- AUClis_0-6h(up to 6 Hours)
- Cmax(up to 6 Hours)
- BGmax(up to 6 Hours)
- tBGmax(up to 6 Hours)
- Compatibility(up to 14 days)
- Adverse Events(up to 12 weeks)
- Local tolerability(up to 12 weeks)