Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study a known investigational medicinal product called semaglutide will be tested in
      four different tablet versions. In addition to semaglutide, the different tablet versions C,
      D, E and F contain different helping agents in different amounts. All tablet versions have a
      helping agent called SNAC. All tablet versions are tested for the treatment of type 2
      diabetes. Recently the European Medicines Agency approved semaglutide in tablet form and
      currently, tablets in the doses 3 mg, 7 mg and 14 mg can be prescribed in some countries. The
      main aim of this study is to test oral semaglutide doses of 25 mg and 50 mg. These are higher
      dosages of oral semaglutide than can be prescribed today. With the 50 mg dose, we expect the
      amount of semaglutide in the blood to be higher than what has been tested before. Further
      aims of this study are to find an optimal version for the semaglutide tablets, and to examine
      the safety and tolerability of the different tablet versions. For this purpose, the amount of
      semaglutide in the blood will be measured after taking different semaglutide tablets, in
      different doses. The version of the tablet participants will receive (i.e. the treatment arm
      participants will be assigned to) is decided by chance.

      In treatment periods 1 and 2 participants will receive one tablet daily over 2 weeks for each
      period. For treatment periods 3 to 5 participants will receive one tablet daily over 4 weeks
      for each period (participants may get 2 tablets per day in treatment period 5). This means
      that treatment will take 16 weeks in total. The tablets should be taken in the morning
      together with no more than half a glass of water (120 mL), after an overnight fast of at
      least 6 hours (no food or drinks). Water is also not allowed from 2 hours before dosing.
      After dosing participants must wait 30-35 minutes before they eat or drink. At home,
      participants must take their breakfast 30-45 minutes after dosing.

      No oral medication (which are taken by mouth) can be taken from 2 hours before and until 30
      minutes after each dosing with semaglutide. The study can last for up to 24 weeks for each
      participant. This includes a screening period (up to 3 weeks), a treatment period (16 weeks)
      and a follow-up visit (5 weeks after the last dosing). Participants will have 11 clinic
      visits with the study doctor. Some of the visits include overnight stays. Participants will
      have blood tests at every visit. Participants must be healthy and have a body mass index
      (BMI) between 21.0 and 29.9 kg/m^2 For women: Women cannot take part in this study if they
      are pregnant, breast-feeding or plan to become pregnant during the study period.
    


Intervention name(s): Oral semaglutide
Intervention type(s): Drug
Intervention description(s): Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment