← Human Trials & Peer-Reviewed Studies
A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes
Plain-language guide to NCT02147431: phase 1 randomized trial of Semaglutide, 38 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02147431
- Phase
- phase 1
- Status
- completed
- Start
- 2014-05-21
- Completion (planned or actual)
- 2015-05-20
- Participants
- 38 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- 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.
It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 38 actual participants took part.
It was open to people of any sex aged from 18 years up to 64 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female, age between18-64 years (both inclusive) at the time of signing informed consent. Body Mass Index (BMI) between 20.0-35.0 kg/m\^2 (both inclusive).
The full record lists 4 inclusion and 3 exclusion criteria.
How the Study Was Run
Design: randomized, crossover and double-blind.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.
Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.
Those kept unaware of assignments: participant and investigator.
It started in 2014-05-21 with completion listed for 2015-05-20.
It ran at 1 site in Austria.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in mean glucagon concentration during hypoglycaemia (change from target level [amount hidden]/L to nadir (target [amount hidden]/L)).
It also tracked 4 secondary outcomes, for example Hypoglycaemic symptoms score.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 38 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.