Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Injection Pain (VAS mm)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
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.
Intervention: sodium chloride 0.9% solution (Drug)
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.
Intervention: 19 injections (Other)
Outcomes
Primary Outcomes
Injection Pain (VAS mm)
Time Frame: 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).
Secondary Outcomes
- 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)