Diabetes
Conditions
Interventions
Semaglutide (0.25 mg) and dulaglutide (0.75 mg) will be given as injections
under the skin of the belly. After each injection subjects are asked to fill in
questionnaires about the level and type of
Sponsors
Novo Nordisk A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. - Body mass index >=25.0 kg/m2. - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the Investigator.
Exclusion criteria
Exclusion criteria: - Female who is pregnant, breast-feeding or intends to become pregnant within 4 weeks of Day 1 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. - Glycosylated hemoglobin (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, contraceptives and occasional use of paracetamol (not allowed within 24 hours prior to drug 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. - Use of tobacco and nicotine products, defined as any of the below: o Smoking more than 1 cigarette or the equivalent per day on average. o 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 study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of injection site pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory endpoints: Categorical assessment of injection site pain More than moderate injection site pain Quality of pain Duration of pain Comparative pain experience | — |
Countries
Netherlands
Outcome results
None listed