Diabetes Mellitus, Type 2
Conditions
Brief summary
NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.
Interventions
DRUGNNC0519-0130
Administered subcutaneously.
DRUGPlacebo
Administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) between 23.0 kilogram per meter square (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator. * For Japanese participants: Both parents of Japanese descent. * For non-Japanese participants: Both parents of Caucasian descent.
Exclusion criteria
* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) at screening. * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period | From pre-dose until 24 hours post-dose relative to last dose in each treatment period | Measured in h\*nmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period | From pre-dose until 24 hours post-dose relative to last dose in each treatment period | Measured in nmol/L. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From time of dosing (day 1) until completion of the follow-up visit (day 105) | Measured as number of events. |
Countries
Japan
Outcome results
None listed