Back to resultsInvestigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
19 injections
sodium chloride 0.9% solution
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes
Eligibility 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)
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Different injection speed and volume combinations
Arm Description
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.
Outcomes
Primary Outcome Measures
Injection Pain (VAS mm)
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
Acceptance of Injection Pain After Injection of Different Volumes.
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.
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.
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01680328
Brief Title
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Official Title
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Different injection speed and volume combinations
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
19 injections
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
sodium chloride 0.9% solution
Intervention Description
Solution for injection.
Primary Outcome Measure Information:
Title
Injection Pain (VAS mm)
Description
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).
Time Frame
1 minute (±30 sec) after each injection
Secondary Outcome Measure Information:
Title
Acceptance of Injection Pain After Injection of Different Volumes.
Description
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
Time Frame
1 minute (±30 seconds) after each injection
Title
Acceptance of Injection Pain After Injection at Different Speeds.
Description
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
Time Frame
1 minute (±30 sec) after each injection
Title
Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.
Description
Acceptance of pain was rated subjectively as yes or no by the subject after each injection.
Time Frame
1 minute (±30 seconds) after each injection
Title
Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion
Description
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.
Time Frame
2 minutes (±30sec) after each injection
Title
Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion
Description
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.
Time Frame
2 minutes (±30sec) after each injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24720741
Citation
Heise T, Nosek L, Dellweg S, Zijlstra E, Praestmark KA, Kildegaard J, Nielsen G, Sparre T. Impact of injection speed and volume on perceived pain during subcutaneous injections into the abdomen and thigh: a single-centre, randomized controlled trial. Diabetes Obes Metab. 2014 Oct;16(10):971-6. doi: 10.1111/dom.12304. Epub 2014 May 11.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
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