A Randomised, Double-blind, Placebo-controlled, Single-dose, Parallel Group Trial With Insulin 454 and SIAM 50 in Healthy Male Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Frequency of adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese passport holder
- •Japanese-born parents
- •Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- •Fasting blood glucose of below or equal to 6 mmol/L
- •Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator
排除标准
- •The receipt of any investigational drug within 3 months prior to this trial
- •Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the Investigator
研究组 & 干预措施
Low dose, insulin degludec
干预措施: insulin degludec (Drug)
Low dose, insulin degludec
干预措施: placebo (Drug)
Medium dose, insulin degludec
干预措施: insulin degludec (Drug)
Medium dose, insulin degludec
干预措施: placebo (Drug)
High dose, insulin degludec
干预措施: insulin degludec (Drug)
High dose, insulin degludec
干预措施: placebo (Drug)
IDegAsp 50
干预措施: placebo (Drug)
IDegAsp 50
干预措施: insulin degludec/insulin aspart 50 (Drug)
结局指标
主要结局
Frequency of adverse events (AEs)
时间窗: From dosing visit and until follow-up 7-21 days after last dosing visit
次要结局
- Area under the serum insulin concentration curve(0-96 hours after dosing)
- Area under the glucose infusion rate curve(0-24 hours after dosing)