Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers. The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.
Interventions
DRUGNNC 0148-0000-0362
Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
DRUGinsulin glargine
As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
DRUGplacebo
Subjects will receive a single dose of oral placebo within each 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
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 18-28 kg/m\^2 (both inclusive) * Subject who is considered to be healthy 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
Exclusion criteria
* Known or suspected hypersensitivity to trial products or related products * Previous participation in this trial. Participation is defined as randomised * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator * Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin concentration-time curve (with Trial part 1) | From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively |
| Area under the glucose infusion rate (GIR)-time curve (Trial part 1) | From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively |
| Area under the serum insulin concentration-time curve (Trial part 2) | From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively |
Countries
Germany
Outcome results
None listed