A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations
研究概览
简要总结
This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.
The aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels.
Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®). NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors.
Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. Which medication participants receive first and which second, insulin NNC0363-0845 or insulin detemir, is decided by chance.
The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. Participants will have frequent contact with the study doctor during the study.
During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions.
Interested parties may not participate in the study if the study doctor believes it will affect their health negatively.
Women cannot take part if they are of childbearing potential.
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)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NNC0363-0845 followed by insulin detemir
Participants will get subcutaneous (under the skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of insulin detemir up to 6 times daily for 3 days.
干预措施: NNC0363-0845 (Drug)
Insulin detemir followed by NNC0363-0845
Participants will get subcutaneous (under the skin) injections of insulin detemir up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of NNC0363-0845 (study medicine) up to 6 times daily for 3 days.
干预措施: Insulin detemir (Drug)
结局指标
主要结局
AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations
时间窗: From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)
messured in h\*mmol/L
次要结局
- ∆PGav,0-1h Mean change in plasma glucose at steady concentrations(From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3))
- ∆PGav,0-2h Mean change in plasma glucose at steady concentrations(From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3))
- Number of adverse events(From first IMP administration until 16 hours after last IMP administration (visit 4 day 3 and visit 5 day 3))
- AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations(From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3))
- AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations(From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3))
- AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations(From 0 to 4 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3))