Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.
Interventions
DRUGInsulin 320
Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.
DRUGinsulin glargine
As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.
DRUGplacebo
Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index 18.5-28.0 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, electrocardiograms 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 signed informed consent * Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol * Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment-emergent adverse events | From the time of trial product administration and until 12 days after trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate-time curve | From 0 to 24 hours after a single dose |
| Area under the serum insulin concentration-time curve | From 0 to 288 hours after a single dose (SD) |
Countries
Germany
Outcome results
None listed