Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People 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
- 28
- 试验地点
- 1
- 主要终点
- Delta AUCBG,0-2h
研究概览
简要总结
Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.
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 (as diagnosed clinically) >= 12 months.
- •Treated with multiple daily insulin injections or CSII >= 12 months.
- •Current total daily insulin treatment < 1.2 (I)U/kg/day.
- •Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
- •Usual Insulin bolus dose between 0.8 and 2 (I)U per 10 g CH (both inclusive). Expecting prandial insulin dose range for standardised meal test between 5 and 12 (I)U.
- •BMI 18.5-28.0 kg/m^2 (both inclusive).
- •HbA1c <= 9.0% by local laboratory analysis
- •Fasting C-peptide <= 0.3 nmol/L.
排除标准
- •Known or suspected hypersensitivity to trial products or related products.
- •Type 2 diabetes mellitus.
- •Previous participation in this trial. Participation is defined as randomised.
- •Participation in any Clinical Trial 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.
- •Women of child bearing potential, not willing to use contraceptive methods.
研究组 & 干预措施
BioChaperone® Combo
1 single dose 400 U/mL
干预措施: Biochaperone® Combo (Drug)
Humalog® Mix25
1 single dose 100 U/mL
干预措施: Humalog® Mix25 (Drug)
结局指标
主要结局
Delta AUCBG,0-2h
时间窗: 2 hours
Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal
次要结局
- Cmax,Glarg(6 hours)
- BGmax(6 hours)
- Delta AUCBG,0-6h(6 hours)
- AUCLisp,0-6h,(6 hours)
- Adverse events(Up to 7 weeks)
- Cmax,Lisp(6 hours)
- Local tolerability(Up to 7 weeks)
- tBGmax(6 hours)
- AUCGlarg,0-6h(6 hours)