Clinical trial NCT01680328: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Injection Pain (VAS mm)
timeFrame: 1 minute (±30 sec) after each injection
Secondary outcomes:
measure: Acceptance of Injection Pain After Injection of Different Volumes.
timeFrame: 1 minute (±30 seconds) after each injection
measure: Acceptance of Injection Pain After Injection at Different Speeds.
timeFrame: 1 minute (±30 sec) after each injection
measure: Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.
timeFrame: 1 minute (±30 seconds) after each injection
measure: Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion
timeFrame: 2 minutes (±30sec) after each injection
measure: Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion
timeFrame: 2 minutes (±30sec) after each injection
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.