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Completed

NCT Number: NCT01680328

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

19 injections

Other

Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).

sodium chloride 0.9% solution

Drug

Solution for injection.

Primary outcomes

  1. 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

  1. Acceptance of Injection Pain After Injection of Different Volumes.

    Time frame: 1 minute (±30 seconds) after each injection

    Acceptance of pain was rated subjectively as yes or no by the subject after each injection.

  2. Acceptance of Injection Pain After Injection at Different Speeds.

    Time frame: 1 minute (±30 sec) after each injection

    Acceptance of pain was rated subjectively as yes or no by the subject after each injection.

  3. Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.

    Time frame: 1 minute (±30 seconds) after each injection

    Acceptance of pain was rated subjectively as yes or no by the subject after each injection.

  4. Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion

    Time frame: 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.

  5. Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2012
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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