Comparing Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)

What Was Tested

This registered phase 4 trial tested Semaglutide.

This study plans to learn more about the effect of semaglutide once weekly on intestinal permeability in individuals with type 2 diabetes.

It had two arms (groups): SC semaglutide (experimental) and Placebo (placebo comparator).

Participants in this arm will be given a once weekly, subcutaneous, placebo injection matching the Semaglutide experimental arm in addition to their background metformin monotherapy.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 69 actual participants took part.

It was open to people of any sex aged from 18 years up to 89 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus on metformin monotherapy. Body mass index (BMI) ≥28 kg/m2.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product or related products; participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening; any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 and investigator.

It started in 2022-01-01 with completion listed for 2024-10-16.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups (time frame: Week 16 (visit 6)).

It also tracked 7 secondary outcomes, for example Differences between treatment groups in plasma LBP, Differences between treatment groups in Serum zonulin, Differences between treatment groups in Fecal Calprotectin, Differences between treatment groups in plasma IL-6, Differences between treatment groups in plasma IL-8 and Differences between treatment groups in plasma TNFα.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 69 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.