Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.
Interventions
DRUGsemaglutide
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule
DRUGplacebo
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male Japanese and Caucasian subjects * Age between 20 and 55 years (both inclusive) at the time of signing informed consent * Body weight of equal to or above 54.0 kg * Body mass index (BMI) between 20.0 and 25.0 kg/m\^2 (both inclusive) * Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0% * For Japanese subjects only: both parents Japanese * For Caucasian subjects only: both parents Caucasian
Exclusion criteria
* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2) * History of chronic pancreatitis or idiopathic acute pancreatitis * Calcitonin above or equal to 50 ng/L * History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits * Smoking of more than 5 cigarettes (including nicotine substitute products) or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure * Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma semaglutide concentration-time curve | During a dosing interval (0-168 hours) at steady state |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed plasma semaglutide concentration at steady state | 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg) |
| Change in body weight from baseline to the end of treatment | Day 1 of Visit 2 (2-21 days after Visit 1), Day 92 |
| Number of treatment emergent adverse events (TEAEs) from baseline to follow-up | From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23) |
Countries
Japan
Outcome results
None listed