A Multiple Dose Study Investigating Pharmacodynamics and Pharmacokinetics of Subcutaneous NNC0363-1063 in Participants With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state
研究概览
简要总结
The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.
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
- None
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 participant (sex at birth) of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e., documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 month without an alternative medical cause) prior to the day of screening.
- •Age 18-64 years (both inclusive) at the time of signing informed consent.
- •Body mass index between 18.5-29.9 Kilogram Per Square Meter (kg/m^2) (both inclusive) at the day of screening.
- •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 ≥ 90 days prior to the day of screening.
- •Glycated haemoglobin (HbA1c) less than or equal to (≤ ) 9.0 percentage (%) at the day of screening.
排除标准
- •Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- •Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
研究组 & 干预措施
Sequence 1
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
干预措施: NNC0363-1063 (Drug)
Sequence 2
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
干预措施: NNC0363-1063 (Drug)
Sequence 3
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
干预措施: NNC0363-1063 (Drug)
Sequence 4
Participants will receive NNC0363-1063 co-administered with and without non-glucose carbohydrate in treatment period 1 and treatment period 2.
干预措施: NNC0363-1063 (Drug)
结局指标
主要结局
AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state
时间窗: Visit 2 and 3: Day 2 and 3
Measured in milligrams per kilogram (mg/kg).
次要结局
- GIRmax,SS: Maximum glucose infusion rate at steady state(Visit 2 and 3: Day 2 and 3)
- Time to maximum glucose infusion rate (tGIRmax),SS: Time to maximum glucose infusion rate at steady state(Visit 2 and 3: Day 2 and 3)
- AUC,I1063,SS: Area under the serum NNC0363-1063 concentration time curve at steady state(Visit 2 and 3: Day 2 and 3)
- Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration at steady state(Visit 2 and 3: Day 2 and 3)
- tmax,I1063,SS: Time to maximum observed serum NNC0363-1063 concentration at steady state(Visit 2 and 3: Day 2 and 3)
- Number of adverse events(Visit 2 and 3: Day 2 and 3)