A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0268-0965 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. Participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. It is the first time that insulin 965 is tested in humans. Participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1 (healthy subjects):
- •Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Part 2 (subjects with type 1 diabetes mellitus):
- •Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.
- •Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilized (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause).
- •Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
- •HbA1c equal to or below 8.5%.
- •Fasting C-peptide below 0.30 nmol/L.
排除标准
- •(Part 1 and Part 2)
- •Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
研究组 & 干预措施
Part 1 (healthy): NNC0268-0965
A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)
干预措施: NNC0268-0965 (Drug)
Part 1 (healthy): placebo
A single dose of placebo (NNC0268-0965) given s.c.
干预措施: Placebo (Drug)
Part 2 (type 1 diabetes): NNC0268-0965
A single dose of NNC0268-0965 given s.c.
干预措施: NNC0268-0965 (Drug)
Part 2 (type 1 diabetes): insulin glargine
A single dose of insulin glargine given s.c.
干预措施: insulin glargine (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Number of events
次要结局
- Number of treatment-emergent hypoglycaemic episodes(From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10)
- Area under the serum NNC0268-0965 concentration-time curve after a single dose(From 0 hours until infinity after trial product administration (day 1))
- Maximum observed serum NNC0268-0965 concentration after a single dose(From 0 hours until last measurement time after trial product administration (day 1))