Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.
Interventions
DRUGinsulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
DRUGinsulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
DRUGplacebo
Oral placebo adminstered corresponding to insulin 287 treatment
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 18.0-28.0 kg/m\^2 * 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 (AEs) | As recorded from trial product administration and until completion of Sub-visit 2G (Day 13) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin concentration-time curve | From 0 to 648 hours after a single dose |
| Area under the glucose infusion rate (GIR)-time curve | From 0 to 24 hours after a single dose |
Countries
Germany
Outcome results
None listed