Diabetes, Diabetes Mellitus, Type 2
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 NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.
Interventions
Each subject will be allocated to one of three dosing periods only. The subject will receive oral insulin 338 and placebo, administered subcutaneously (s.c., under the skin) once daily for 10 days at fixed dose levels.
DRUGplacebo
S.c placebo administered in combination with insulin 338
DRUGinsulin glargine
Each subject will be allocated to one of three dosing periods only. The subject will receive insulin glargine for s.c. administration and oral placebo once daily for 10 days at fixed dose levels.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L) * Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive) * Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more
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 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 treatment emergent adverse events | As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin concentration-time curve | During one dosing interval (0-24 hours) at steady-state (Day 10) |
| Area under the glucose infusion rate-time curve | During one dosing interval (0-24 hours) at steady state (Day 10) |
Countries
Germany
Outcome results
None listed