A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAE)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes.
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
- Double (Participant, Investigator)
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, age between 18 and 64 years (both inclusive) at the time of signing informed consent.
- •Subject who is considered to be generally healthy (with the exception of conditions associated with diabetes mellitus), based on the medical history, physical examination, and the results of vital signs, ECG and laboratory safety tests, as judged by the investigator.
- •Body mass index between 20.0 and 34.9 kg/m^2 (both inclusive).
- •Type 2 diabetes mellitus (as diagnosed clinically) for ≥12 months (365 days).
- •No change in insulin treatment regimen during the last 90 days prior to screening.
- •Current total daily insulin treatment between 0.3 and 1.0 (I) U/kg/day (both inclusive).
排除标准
- •Known or suspected hypersensitivity to trial products or related products.
- •Female who is pregnant, breast-feeding, or intending to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by regulation or practice)(highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation,hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner). Females who are not postmenopausal can participate in the study if they use adequate contraceptive methods. Postmenopausal is defined as women aged <52 years and being amenorrheic for more than one year with serum follicle stimulating hormone (FSH level >40 IU/L or aged ≥ 52 years and being amenorrheic for less than one year and with serum FSH level > 40 IU/L or aged ≥ 52 years being amenorrheic for more than one year.
- •Receipt of any investigational medicinal product within 3 months before the screening visit of this trial.
- •History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator.
- •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.
- •Use of oral antidiabetic drugs (OADs) or GLP-1 receptor agonists (e.g. exenatide, liraglutide) within 3 months prior to screening.
研究组 & 干预措施
Insulin 287 + placebo
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
干预措施: Insulin icodec (Drug)
Insulin 287 + placebo
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
干预措施: placebo (Drug)
Insulin degludec + placebo
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
干预措施: insulin degludec (Drug)
Insulin degludec + placebo
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAE)
时间窗: From the first trial product administration at day 1 until completion of the post-treatment follow-up visit (day 68 - 79)
次要结局
- AUCGIR,0-24h,SS, area under the glucose infusion rate-time curve at steady state(At day 30 and day 35)
- AUCI287,τ,SS, area under the steady-state serum insulin 287 concentration-time curve(During one dosing interval at steady-state from 0 to 168 hours after last dose (day 29))