Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Injection Pain (VAS mm)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities.
- •Type 1 or type 2 diabetes
- •Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months
- •Body mass index (BMI) between 18.5 and 30.0 kg/m^2 (both included)
- •Caucasians
排除标准
- •Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
- •Previous participation in this trial. Participation is defined as: screened
- •Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
- •Injection of more than 40 units of insulin per injection
- •Continuous Subcutaneous Insulin Infusion use within the last 6 months
- •Continuous Glucose Monitoring use within the last 6 months
- •Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
- •Known active or in-active skin disease in the injection area or that may affect pain perception
- •Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)
研究组 & 干预措施
Different injection speed and volume combinations
The study consists of 80 treatment arms in a cross-over design with 19 treatments and 19 periods. The 80 treatment arms will represent different orders of the 19 treatments and each treatment arm will be used for one subject. A subject not completing all treatments will be replaced by another subject using the same treatment arm.
干预措施: 19 injections (Other)
Different injection speed and volume combinations
The study consists of 80 treatment arms in a cross-over design with 19 treatments and 19 periods. The 80 treatment arms will represent different orders of the 19 treatments and each treatment arm will be used for one subject. A subject not completing all treatments will be replaced by another subject using the same treatment arm.
干预措施: sodium chloride 0.9% solution (Drug)
结局指标
主要结局
Injection Pain (VAS mm)
时间窗: 1 minute (±30 sec) after each injection
Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).
次要结局
- Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion(2 minutes (±30sec) after each injection)
- Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.(1 minute (±30 seconds) after each injection)
- Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion(2 minutes (±30sec) after each injection)
- Acceptance of Injection Pain After Injection at Different Speeds.(1 minute (±30 sec) after each injection)
- Acceptance of Injection Pain After Injection of Different Volumes.(1 minute (±30 seconds) after each injection)