A Randomized, Monocentric, Double-blind, Multiple Daily Dose, Two-period, 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUCΔBG0-2h (timepoint 0 = administration of the meal)
研究概览
简要总结
This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. The assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes).
Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be performed during the 14 day treatment periods.
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 (as diagnosed clinically) ≥ 12 months
- •Treated with multiple daily insulin injections (no pump users) ≥ 12 months
- •Current total daily insulin treatment <1.2 (I)U/kg/day
- •Body mass index (BMI) 18.5-28.0 kg/m² (both inclusive)
- •HbA1c (N-(1-deoxy)-fructosyl-haemoglobin) ≤ 9.0% by local laboratory analysis
- •Fasting C-peptide ≤ 0.30 nmol/L
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Type 2 diabetes mellitus
- •Patients using continuous subcutaneous insulin infusion (CSII)
- •Previous participation in this trial. Participation is defined as randomised
- •The receipt of any investigational product within 3 months 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 gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), 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
- •Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial
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
AUCΔBG0-2h (timepoint 0 = administration of the meal)
时间窗: 2 hours
Incremental area under the blood glucose (BG) concentration-time curve from 0-2 hours after a meal on day 1-3 \[comparison between treatments Biochaperone insulin lispro vs. lispro (Humalog®)\]
AUClispro 0-30min (timepoint 0 = time of dosing)
时间窗: 30 minutes
Area under the serum insulin lispro concentration-time curve from 0-30 minutes after bolus dose on one of days 1, 2 or 3 (comparison between treatments BioChaperone insulin lispro vs. lispro (Humalog®))
次要结局
- AUClispro_0-6h(6 Hours)
- Cmax_lispro(up to 6 Hours)
- Tmax_lispro(up to 6 Hours)
- AUCBG_0-6h(6 Hours)
- ΔBGmax(6 Hours)
- Adverse events(Up to 3 months)
- Local tolerability injection site reactions(14 days)