A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin 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
- 24
- 试验地点
- 1
- 主要终点
- CmaxPram
研究概览
简要总结
This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.
详细描述
This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.
Each subject will be randomly allocated to a sequence of three treatments:(i) simultaneous administrations of BioChaperone® pramlintide human insulin (BC Pram Ins) and placebo, (ii) simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®) and (iii) simultaneous injections of insulin lispro (Humalog®) and placebo.
Subjects will come in a fasted state to the clinical trial centre in the morning, meal test procedures will be performed and subjects will stay at the clinical trial centre until the post-dose follow-up period has been terminated.
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, 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
- •Male or female subjects aged 18-64 years (both inclusive)
- •Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months
- •Treated with multiple daily insulin injections ≥ 12 months
- •Treated with an evening dose of once-daily insulin glargine U100 at screening
- •Fasting C-peptide ≤ 0.30 nmol/L
排除标准
- •Known or suspected hypersensitivity to IMPs, paracetamol (acetaminophen) or related products
- •Type 2 diabetes mellitus
- •Clinically significant abnormal haematology, biochemistry, 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, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption
- •Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening
研究组 & 干预措施
BC Pram Ins
Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: BC Pram Ins (Drug)
BC Pram Ins
Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Placebo (Drug)
Symlin® and Humulin®
Simultaneous subcutaneous injections avec pramlintide and human insulin
干预措施: Symlin® and Humulin® (Drug)
Humalog®
Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Humalog® (Drug)
Humalog®
Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
干预措施: Placebo (Drug)
结局指标
主要结局
CmaxPram
时间窗: From 0 to 8 hours
Maximum pramlintide concentration
AUCPram_0-8h
时间窗: From 0 to 8 hours
Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration
次要结局
- Pharmacokinetics of insulins(From 0 to 8 hours)
- Glucose pharmacodynamics(From 0 to 8 hours)
- Safety and tolerability (Adverse Events recording)(From 0 to 8 hours)
- Pharmacokinetics of pramlintide(From 0 to 8 hours)