A Randomised, Monocentric, Double-blind, Multiple Daily Dose, Two-period 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualised Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Pharmacodynamics: ΔAUCBG 0-2h
研究概览
简要总结
This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus ≥ 12 months
- •Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy)
- •Current total daily insulin treatment <1.2 (I)U/kg/day
- •Body Mass Index below or equal to 40.0 kg/m²
- •HbA1c ≤ 9.0% by local laboratory analysis
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Type 1 diabetes mellitus
- •Previous participation in this trial
- •The receipt of any investigational 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 gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator
- •Presence of renal impairment (Estimated Glomerular filtration Rate (eGFR)<60 milliliters/minute/1.73m²)
- •Presence of late diabetic complications and/or acute coronary heart disease.
- •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
- •Current treatment with corticosteroids
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
Pharmacodynamics: ΔAUCBG 0-2h
时间窗: 2 hours
Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)
Pharmacokinetics: AUClis 0-30min
时间窗: 30 minutes
Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)
次要结局
- AUClisp_0-6h(up to 6 hours)
- Cmax_lisp(up to 6 hours)
- tmax_lisp(up to 6 hours)
- CmaxBG(up to 6 hours)
- AUCBG_0-6h(up to 6 hours)
- Adverse Events(up to 8 weeks)
- Local tolerability(up to 8 weeks)