← Human Trials & Peer-Reviewed Studies
A Study Comparing the Injection Site Pain Experience After the Injection of Semaglutide B and Semaglutide D With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity
Plain-language guide to NCT04143945: phase 2 randomized trial of Semaglutide, 104 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04143945
- Phase
- phase 2
- Status
- completed
- Start
- 2019-10-28
- Completion (planned or actual)
- 2020-01-04
- Participants
- 104 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Healthy Volunteers Diabetes Mellitus, Type 2; Healthy Volunteers Overweight; Healthy Volunteers Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Semaglutide.
The 2 injections will be given at least 30 minutes apart, one in each side of the stomach.
It had two arms (groups): DV3396 followed by PDS290 (experimental) and PDS290 followed by DV3396 (experimental).
The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach.
The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach.
The registry classes the interventions as drug.
Who Took Part
104 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing informed consent. BMI equal to or above 25.0 kg/m\^2.
The full record lists 4 inclusion and 26 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; previous participation in trial ins-4604 or ins-4582. participation is defined as having received investigational product; any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
How the Study Was Run
Design: randomized, crossover and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
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, care provider, investigator and outcomes assessor.
It started in 2019-10-28 with completion listed for 2020-01-04.
It ran at 1 site in Netherlands.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Intensity of Injection Site Pain (time frame: After 1 minute of each injection (Day 1)).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Semaglutide in 104 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.