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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01680328
First received: August 31, 2012
Last updated: May 19, 2014
Last verified: May 2014

August 31, 2012
May 19, 2014
August 2012
October 2012   (final data collection date for primary outcome measure)
Injection Pain (VAS mm) [ Time Frame: 1 minute (±30 sec) after each injection ] [ Designated as safety issue: No ]
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).
Injection pain rated on a Visual Analogue Scale (VAS) in millimetres (mm) [ Time Frame: 1 minute (±30 sec) after the injection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01680328 on ClinicalTrials.gov Archive Site
  • Acceptance of Injection Pain After Injection of Different Volumes. [ Time Frame: 1 minute (±30 seconds) after each injection ] [ Designated as safety issue: No ]
    Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
  • Acceptance of Injection Pain After Injection at Different Speeds. [ Time Frame: 1 minute (±30 sec) after each injection ] [ Designated as safety issue: No ]
    Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
  • Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen. [ Time Frame: 1 minute (±30 seconds) after each injection ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 minutes (±30sec) after each injection ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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 pain for each injection (including the needle insertions only) as a binary measure [ Time Frame: Measured 1 minute (±30 seconds) after the injections ] [ Designated as safety issue: No ]
  • Back flow at the injection site measured as absorbed amount of liquid with filter-paper [ Time Frame: Two minutes (±30 sec) after the injection rated according to a liquid scale ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Delivery Systems
  • Other: 19 injections
    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).
  • Drug: sodium chloride 0.9% solution
    Solution for injection.
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.
Interventions:
  • Other: 19 injections
  • Drug: sodium chloride 0.9% solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
October 2012
October 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01680328
INS-4011, U1111-1129-4191
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP