← Human Trials & Peer-Reviewed Studies
Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects
Plain-language guide to NCT02022254: phase 1 interventional trial of Semaglutide, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02022254
- Phase
- phase 1
- Status
- completed
- Start
- 2013-12-17
- Completion (planned or actual)
- 2014-08-28
- Participants
- 24 (actual)
- Design
- open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2; Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Semaglutide.
This trial is conducted in Europe and Asia.
It had 1 arm (groups): Semaglutide administrations (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 24 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 23 and 30 kg/m\^2 (both inclusive).
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: smoking, drug or alcohol abuse.
How the Study Was Run
Design: crossover and open-label.
Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
It started in 2013-12-17 with completion listed for 2014-08-28.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Area under the metformin plasma concentration-time curve. Area under the S-warfarin plasma concentration-time curve. Area under the R-warfarin plasma concentration-time curve.
It also tracked 4 secondary outcomes, for example Maximum observed metformin plasma concentration at steady state and Incremental area under the INR (international normalised ratio) -curve.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Semaglutide in 24 people.
Its size is small, so on its own it can only give an early look.
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.