Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01680328
First received: August 31, 2012
Last updated: November 7, 2012
Last verified: November 2012
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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.
| 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:
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 [ 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01680328 History of Changes |
| Other Study ID Numbers: | INS-4011, U1111-1129-4191 |
| Study First Received: | August 31, 2012 |
| Last Updated: | November 7, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 May 23, 2013