A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
Status:
Completed
Trial end date:
2021-05-26
Target enrollment:
Participant gender:
Summary
The goal of this trial is to find out whether taking semaglutide tablets at different times
before and after eating has a similar effect compared to the recommended dosing time.
Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach,
and they should not eat, drink, or take any oral medicine for at least 30 minutes after that.
The trial will look at how different dosing times of semaglutide before and after eating a
meal changes how much semaglutide participants get into their blood. Participants will get
one semaglutide tablet daily for a total of 10 days. For the first 5 days participants will
receive semaglutide tablets of 3 mg and for the next 5 days, participants will receive
semaglutide tablets of 7 mg. From here onwards, semaglutide tablets will be referred to as
the 'trial medicine', unless specifically mentioned. Participants will get the trial medicine
(3 mg and 7 mg) under one of the 5 following dosing conditions. It will be decided by chance
under which dosing condition participants will receive the trial medicine: A 2 hour fast
before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test
arm A), A 4 hour fast before taking the trial medicine and 30 minutes fast after taking the
trial medicine (Test arm B), A 6 hour fast before taking the trial medicine and 30 minutes
fast after taking the trial medicine (Test arm C), A 2 hour fast before taking the trial
medicine and an overnight fast (at least 6 hours fast) after taking the trial medicine (Test
arm D), An overnight fast before taking the trial medicine and 30 minutes fast after taking
the trial medicine (Reference arm E). Before each fasting period prior to receiving the trial
medicine, participants will fast for 4 hours and then receive a standardised meal. The meal
should be completed before the 2, 4 or 6 hours fasting is started. The trial will last for
about 48 to 78 days (about 1.5 to 2.5 months). Participants will have 4 scheduled visits with
the study doctor. At one of the visits, participants will be admitted to the trial unit and
have to stay for 12 consecutive days. At all visits participants will meet with trial staff
and will have blood tests along with other clinical checks and tests. Participants will be
asked about their health, medical history, and habits. Women only: Women cannot take part if
pregnant, breast-feeding, or planning to become pregnant during the trial period.