A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events
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 subcutaneously administered NNC0148-0287 (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
- •Females of no childbearing potential [if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L]
- •Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive)
- •Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Receipt of any investigational medicinal products within 3 months before screening
- •Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
研究组 & 干预措施
Insulin 287 + placebo
Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
干预措施: Insulin icodec (Drug)
Insulin 287 + placebo
Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
干预措施: placebo (Drug)
Insulin degludec + placebo
Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
干预措施: insulin degludec (Drug)
Insulin degludec + placebo
Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events
时间窗: From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65)
次要结局
- Area under the steady-state serum insulin 287 concentration-time curve(During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29))
- area under the glucose infusion rate - time curve at steady-state(At Day 31 and day 35)