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Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men
Plain-language guide to NCT03638778: phase 1 randomized trial of Semaglutide, 105 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03638778
- Phase
- phase 1
- Status
- completed
- Start
- 2018-08-17
- Completion (planned or actual)
- 2018-12-05
- Participants
- 105 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Semaglutide.
This study looks at different tablets with a new study medicine called semaglutide.
It is to treat diabetes.
The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body.
It had four arms (groups): Oral semaglutide (reference) (active comparator), Oral semaglutide formulation B (experimental), Oral semaglutide formulation C (experimental) and Oral semaglutide formulation D (experimental).
Participants will receive oral semaglutide (reference) for 10 days.
Participants will receive oral semaglutide formulation B for 10 days.
Participants will receive oral semaglutide formulation C for 10 days.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 105 actual participants took part.
It was open to men only aged from 18 years up to 64 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 0 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
The Semaglutide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
It started in 2018-08-17 with completion listed for 2018-12-05.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Number of treatment emergent adverse events.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 105 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.