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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
S.c placebo administered in combination with insulin 338
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.
Novo Nordisk Investigational Site
Neuss, Germany
Number of treatment emergent adverse events
Time frame: As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit
Area under the serum insulin concentration-time curve
Time frame: During one dosing interval (0-24 hours) at steady-state (Day 10)
Area under the glucose infusion rate-time curve
Time frame: During one dosing interval (0-24 hours) at steady state (Day 10)
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Oral placebo administered in combination with s.c. insulin glargine