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

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ClinicalTrials.gov Identifier: NCT01680328
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : June 19, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Other: 19 injections Drug: sodium chloride 0.9% solution Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Study Start Date : August 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680328


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01680328    
Other Study ID Numbers: INS-4011
U1111-1129-4191 ( Other Identifier: WHO )
First Posted: September 7, 2012    Key Record Dates
Results First Posted: June 19, 2014
Last Update Posted: March 3, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases