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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
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.
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Oral placebo adminstered corresponding to insulin 287 treatment
Novo Nordisk Investigational Site
Neuss, Germany
Number of adverse events (AEs)
Time frame: As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)
Area under the serum insulin concentration-time curve
Time frame: From 0 to 648 hours after a single dose
Area under the glucose infusion rate (GIR)-time curve
Time frame: From 0 to 24 hours after a single dose
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