A Trial Investigating the Pharmacokinetic Properties of Five Formulations of Fast-acting Insulin Aspart 200 U/mL in Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
研究概览
简要总结
This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).
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)
盲法说明
Sponsor staff involved in the clinical trial is asked according to company standard procedures
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, aged 18-64 years (both inclusive) at the time of signing informed consent
- •Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
- •Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening
排除标准
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial
- •Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening
- •Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods
研究组 & 干预措施
Group A
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster Aspart 200 U/mL (Drug)
Group A
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster aspart 100 U/mL (Drug)
Group B
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster Aspart 200 U/mL (Drug)
Group B
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster aspart 100 U/mL (Drug)
Group C
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster Aspart 200 U/mL (Drug)
Group C
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster aspart 100 U/mL (Drug)
Group D
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster Aspart 200 U/mL (Drug)
Group D
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster aspart 100 U/mL (Drug)
Group E
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster Aspart 200 U/mL (Drug)
Group E
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster aspart 100 U/mL (Drug)
Group F
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster Aspart 200 U/mL (Drug)
Group F
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence:
formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A.
The dosing visits will be separated by wash-out periods (2-21 days).
干预措施: Faster aspart 100 U/mL (Drug)
结局指标
主要结局
AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
时间窗: 0 to 10 hours after IMP administration
Measured in pmol\*h/L
次要结局
- AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration(0 to 1 hour after IMP administration)
- AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration(0 to 2 hours after IMP administration)
- AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity(0 to 10 hours after IMP administration)
- Cmax,IAsp - Maximum observed serum insulin aspart concentration(0 to 10 hours after IMP administration)
- tmax,IAsp - Time to maximum observed serum insulin aspart concentration(0 to 10 hours after IMP administration)
- Number of adverse events in the treatment emergent period(0 to 2 days after IMP administration)
- Number of local reactions at the injection site in the treatment emergent period(0 to 2 days after IMP administration)
- Number of hypoglycaemic episodes in the treatment emergent period(0 to 16 hours after IMP administration)