Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.
Interventions
DRUGNNC 0123-0000-0338
Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.
DRUGplacebo
Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.
DRUGinsulin glargine
As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.
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
* Male subject * Body mass index (BMI) between 18 and 28 kg/m\^2 (both inclusive)
Exclusion criteria
* Known or suspected hypersensitivity to trial products or related products * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician * Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | from trial product administration and until completion of the dosing visit (Day 0 to Day 6) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin concentration-time curve | from 0 to 120 hours after a single dose |
| Area under the glucose infusion rate-time curve | from 0 to 24 hours after a single dose |
Countries
Germany
Outcome results
None listed