Phase 1
N=82
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Diabetes · Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2 · Delivery Systems
Bottom Line
View on ClinicalTrials.gov: NCT01680328 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Injection Pain (VAS mm) — 20.0; 12.8; NA; NA mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 19 injections (Other); sodium chloride 0.9% solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Injection Pain (VAS mm) |
20.0; 12.8; NA; NA; NA; NA | — |
| SECONDARY Acceptance of Injection Pain After Injection of Different Volumes. |
334; 218; 303; 368; 75; 28 | — |
| SECONDARY Acceptance of Injection Pain After Injection at Different Speeds. |
432; 365; 426; 59; 44; 66 | — |
| SECONDARY Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen. |
390; 978; 101; 87 | — |
| SECONDARY Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion |
0.0; NA; NA; NA; NA; NA | — |
| SECONDARY Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion |
0.8; NA; NA; NA; NA; NA | — |
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)
Data sourced from ClinicalTrials.gov (NCT01680328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.