Healthy Participants
Conditions
Brief summary
The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.
Interventions
DEVICESyringe Pump
Device used for delivery of subcutaneous injections and infusions of NaCl solution.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Sponsor staff involved in the clinical trial is masked according to company standard procedures. Sponsor is unblinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Healthy male or female participants as judged by the investigator. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 30.0 kilograms per square metre (kg/m\^2) (both included). * White (Light skin that allows for adequate medical evaluation of any skin reactions).
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Previous randomisation in this study. * Previous rescreening for this study. * Pregnant or breastfeeding female participants. * Current participation (i.e., signed informed consent) in any other interventional clinical study. Treatment with an investigational medical product within 3 months or 5 half-lives (if known), whichever is longer prior to screening. * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol, including insufficient abdominal area for injection. * Intake of any medication that could influence pain perception or injection site reaction appearance (e.g., anti-coagulants, including low dose of aspirin, systemic antihistamines, pain-relieving, or anti-inflammatory medicinal products) within the last week before the intervention. * Intake of alcohol within the last 24 hours (self-reported) or a positive result of alcohol breath test prior to randomisation and intervention. * Intake of illicit drugs within the last 48 hours (self-reported) or a positive result of urine drug screening prior to screening. * Use of any nicotine products within the past month before screening. * Known active or inactive skin condition or disease, tattoos, or other interventions in the injection area that may affect pain perception or assessment of injection-site reactions. * Strenuous exercise within 3 days prior to the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injection pain rated on a Visual Analogue Scale (VAS) | 1 minute (±1 minute) from the injection initiation | The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in millimetres (mm). |
| Injection pain rated on a VAS | 9 minutes (±1minute) from the injection initiation | The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of pain for each injection (including the needle insertions only) as a binary measure | 1 minute (±1 minute) from the injection initiation | Measured as binary response (Acceptable/Not acceptable). |
| Back flow at the injection site | 5 minutes (±1 minute) from the injection initiation | Measured in microlitres (μL). |
| Number of acute injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation) after each injection | 9 minutes (±1 minute) from the injection initiation | Measured in injection site reactions (events). |
| Number of long term injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation) | 16-40 hours after all injections with an additional 36 hours if a clinic visit is needed | Measured in injection site reactions (events). |
| Number of adverse events | Up to 40 hours after completing all the injections with an additional 36 hours if a clinic visit is needed | Measured in events. |
Countries
Denmark
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed