n.a. n.a.
Conditions
Interventions
Before the first administration of a study product a grid will be drawn on
volunteers abdomen with a permanent marker. This grid must still be visible
until 7 days after the last injection to be abl
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent. •BMI >=25.0 and
Exclusion criteria
Exclusion criteria: •Female who is pregnant, breast-feeding or intends to become pregnant within 1 week of Day 2 or is of childbearing potential and not using highly effective contraceptive methods. •Any disorder which in the Investigator*s opinion might jeopardise subject*s safety, evaluation of results, or compliance with the protocol. •Glycated haemoglobin (HbA1c) >=6.5 % (48 mmol/mol) at screening. •Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication (when not used in the abdominal area), contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to Trial Product administration), within 14 days prior to Day 1. •Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits. •Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre. •Use of tobacco and nicotine products, defined as any of the below: -Smoking more than 1 cigarette or the equivalent per day on average. -Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period. •Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the trial requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of injection site pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory: -Categorical assessment of intensity of injection site pain -Quality of pain -Duration of pain | — |
Countries
Netherlands
Outcome results
None listed