Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide and Dulaglutide.

This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin).

The 2 injections will be given at least 30 minutes apart, one in each side of the stomach.

It had two arms (groups): Semaglutide followed by dulaglutide (experimental) and Dulaglutide followed by semaglutide (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

The registry lists 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 trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. Body mass index 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-4603, ins-4582 or nn9535-4648. 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.

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.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-12-03 with completion listed for 2020-01-29.

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: 1 minute after each injection (Day 1)).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide and Dulaglutide 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 and the Dulaglutide compound page, all human trials.