Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
• Interventions: Other: 19 injections; Drug: sodium chloride 0.9% solution

• Registration Number: NCT01680328
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-12-06
• Results First Submitted QC: 2014-05-19
• Results First Posted: 2014-06-19
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Different injection speed and volume combinations	sodium chloride 0.9% solution	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.
Different injection speed and volume combinations	19 injections	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.

Primary Outcome Measures

Name	Time	Method
Injection Pain (VAS mm)	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 Outcome Measures

Name	Time	Method
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	Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.	1 minute (±30 seconds) after each injection	Acceptance of pain was rated subjectively as yes or no by the subject 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	Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.
Acceptance of Injection Pain After Injection at Different Speeds.	1 minute (±30 sec) after each injection	Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
Acceptance of Injection Pain After Injection of Different Volumes.	1 minute (±30 seconds) after each injection	Acceptance of pain was rated subjectively as yes or no by the subject after each injection.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany