This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
107
Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.
Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.
Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.
Placebo semaglutide. For oral administration.
Placebo semaglutide with carrier. For oral administration.
Novo Nordisk Investigational Site
Berlin, Germany
Number of treatment emergent adverse events (TEAEs) recorded
Time frame: From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)
Area under the plasma concentration curve over the dosing interval (0-24 hours)
Time frame: After the last 3 daily doses for semaglutide and carrier
Change from baseline in fasting plasma glucose (FPG)
Time frame: Week 0, week 10 (Day 69)
Change from baseline in C-peptide
Time frame: Week 0, week 10 (Day 69)
Change from baseline in insulin
Time frame: Week 0, week 10 (Day 69)
Change from baseline in glucagon
Time frame: Week 0, week 10 (Day 69)
Change from baseline in glycosylated haemoglobin type A1c (HbA1c)
Time frame: Week 0, week 10 (Day 69)
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