A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 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
- AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
研究概览
简要总结
The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 32 weeks in total.
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 masked 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 2 diabetes mellitus more than or equal to 180 days prior to the day of screening
- •Body weight between 80.0 to 120.0 kg (both inclusive)
- •Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)
- •No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records)
- •Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening: a) Any metformin formulation (dose as documented in the subject medical record), b) One other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: Insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium glucose co-transporter 2 (SGLT2) inhibitor
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
- •Receipt of any investigational medicinal product within 90 days before screening
- •History of severe allergies to drugs or foods or a history of severe anaphylactic reaction
研究组 & 干预措施
Semaglutide plus insulin 287
Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).
干预措施: NNC0148-0287sema (Drug)
Semaglutide alone
Participants will get a single dose of semaglutide (treatment B) alone.
干预措施: Semaglutide (Drug)
Insulin 287 alone
Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone.
干预措施: NNC0148-0287 (Drug)
结局指标
主要结局
AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
时间窗: 0-840 hours
Measured in pmol\*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose
时间窗: 0-840 hours
Measured in pmol\*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
次要结局
- tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose(0-840 hours)
- Cmax, I287, maximum observed serum insulin 287 concentration after a single dose(0-840 hours)
- tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose(0-840 hours)
- Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin(Day 36 (end of period))
- AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose(0-840 hours)
- Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose(0-840 hours)
- Number of treatment emergent adverse events(Day 1 (beginning of each period) to day 36 (end of each period))
- Number of hypoglycaemic episodes(Day 1 (beginning of each period) to day 36 (end of each period))
- Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies(Day 36 (end of period))
- AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose(0-840 hours)
- Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)(Day 36 (end of period))
- Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1(Day 151 (follow-up/end-of-trial visit))
- Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels(Day -1 (pre-dose), Day 36 (end of period))
- Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels(Day -1 (pre-dose), Day 36 (end of period))
- Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin(Day 151 (follow-up/end-of-trial visit))
- Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1(Day 151 (follow-up/end-of-trial visit))
- Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies(Day 36 (end of period))
- Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels(Day 151 (follow-up/end-of-trial visit))
- Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels(Day 151 (follow-up/end-of-trial visit))
- Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies(Day 151 (follow-up/end-of-trial visit))