Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.
Interventions
DRUGliraglutide
Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
DRUGplacebo
Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) between 18 and 27 kg/m\^2, inclusive
Exclusion criteria
* Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator or Sub-Investigator * Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the Investigator * Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmHg systolic or 40-90 mmHg diastolic * Heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min * Alcohol intake within 48 hours prior to the screening * Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive * Clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the Investigator * History of significant allergy or hypersensitivity * Known or suspected allergy to trial product or related products * History of drug or alcohol abuse * Smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | — |
| Vital signs (Blood pressure) | — |
| Vital signs (Pulse rate) | — |
| ECG (ElectroCardioGram) | — |
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour insulin profile in serum | — |
| Area under the plasma NNC 90-1170 curve | — |
| 24-hour glucagon profile in plasma | — |
| Maximum plasma NNC 90-1170 concentration, Cmax | — |
| Time to maximum plasma NNC 90-1170 concentration, tmax | — |
| Terminal elimination half-life, t1/2 | — |
| 24-hour glucose profile in serum | — |
Countries
Japan
Outcome results
None listed