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: October 14, 2013
Last verified: October 2013
  Purpose

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 back flow.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Other: No treatment given
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Acceptance of pain for each injection (including the needle insertions only) as a binary measure (yes/no) [ 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 ]

Enrollment: 82
Study Start Date: August 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Different injection speed and volume combinations Other: No treatment given
Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of these 19 injections two 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).

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680328

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Berit Gorsøe Kjeldsen Novo Nordisk A/S
Study Director: Marianne Qvist Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01680328     History of Changes
Other Study ID Numbers: INS-4011, U1111-1129-4191
Study First Received: August 31, 2012
Last Updated: October 14, 2013
Health Authority: Germany: Institutional Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014