type 2 diabetes
Conditions
Interventions
Single dose of subcutaneous NNC0480-0389 (1.7 mg, 8.6 mg or 30 mg) and semaglutide (0.5 mg only) or a single dose of subcutaneous NNC0480-0389 placebo and semaglutide placebo as separate injections
Sc
Sponsors
Hashida Masahiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Male aged 20-55 years (both inclusive) at the time of signing the informed consent. - Both parents of Japanese descent. - Body mass index between 20.0 kg/m2 and 24.9 kg/m2 (both inclusive). - 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: -Any disorder which in the investigators opinion might jeopardise subjects safety or compliance with the protocol. - HbA1c >= 6.5% (48 mmol/mol) at screening. - Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening. - Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| - Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose - Maximum plasma concentration of NNC0480-0389 upon a single-dose - Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose - Maximum plasma concentration of semaglutide upon a single-dose | — |
Contacts
Public ContactMasahiro Hashida
Novo Nordisk Pharma Ltd.
Outcome results
None listed