A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Co-formulation of an Insulin Analog and Pramlintide in Subjects 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 trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.
详细描述
In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.
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
- •Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months
- •Treated with multiple daily injection ≥ 12 months
- •Treated with insulin glargine U100 or U300 or insulin detemir at screening
- •Fasting C-peptide ≤ 0.30 nmol/L
- •BMI: 18.5-28.0 kg/m² (both inclusive)
排除标准
- •Known or suspected hypersensitivity to IMPs, paracetamol or related products
- •Type 2 Diabetes Mellitus
- •Clinically significant abnormal haematology, biochemistry or urinalysis screening test, 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
Co-formulation of insulin analog and pramlintide (ADO09)
Subcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy.
干预措施: ADO09 formulation (Drug)
Co-formulation of insulin analog and pramlintide (ADO09)
Subcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy.
干预措施: Placebo (Drug)
Humulin® + Symlin®
Simultaneous, separate subcutaneous injections of human insulin and pramlintide.
干预措施: Symlin® (Drug)
Humulin® + Symlin®
Simultaneous, separate subcutaneous injections of human insulin and pramlintide.
干预措施: Humulin® (Drug)
Humalog®
Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy.
干预措施: Placebo (Drug)
Humalog®
Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy.
干预措施: Humalog® (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
CmaxIns
时间窗: From 0 to 8 hours
Maximum insulin analog concentration
AUCIns 0-8h
时间窗: From 0 to 8 hours
Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration
次要结局
- Pharmacokinetics of pramlintide(From 0 to 8 hours)
- Glucose pharmacodynamics(From 0 to 8 hours)
- Pharmacokinetics of insulins(From 0 to 8 hours)
- Safety and tolerability (Adverse Events recording)(From 0 to 8 hours)