A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number and severity of adverse events for trial part 1
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.
The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •FOR TRIAL PART 1, THE FOLLOWING APPLIES:
- •Gender: male
- •Age: 18-55 years
- •BMI (body mass index): 18-28 kg/m2
- •Study participants considered to be healthy
- •FOR TRIAL PART 2, THE FOLLOWING APPLIES:
- •Gender: male or female of no childbearing potential
- •Age: 18-65 years
- •Type 1 diabetes: BMI (body mass index): 18-28 kg/m2
- •Type 2 diabetes: BMI (body mass index): 22-35 kg/m2
- •Type 1 or type 2 diabetes for at least 12 months
- •Type 1 diabetes: Treatment with insulin for at least 12 months
- •Type 2 diabetes: Treatment with insulin for at least 3 months
排除标准
- •Known or suspected allergy to the trial product or related products
- •Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
- •Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
研究组 & 干预措施
Trial part 1
干预措施: NN1952 (Drug)
Trial part 1
干预措施: insulin aspart (Drug)
Trial part 1
干预措施: placebo (Drug)
Trial part 2
干预措施: NN1952 (Drug)
Trial part 2
干预措施: insulin aspart (Drug)
Trial part 2
干预措施: placebo (Drug)
结局指标
主要结局
Number and severity of adverse events for trial part 1
时间窗: from visit 1 to visit 3
Number and severity of adverse events for trial part 2
时间窗: from visit 1 to visit 6
次要结局
- Area under the serum insulin concentration-time curve after a single dose(after 12 hours)
- Area under the glucose infusion rate-time curve after a single dose(after 12 hours)