Treatment of GLP-1 for Diabetic Bariatric Patients

What Was Tested

The trial (phase 4) is built around Semaglutide.

This study is for patients that are diabetic, and require insulin for glycemic control, and going through the bariatric surgery process.

It had two arms (groups): Control Arm (placebo comparator) and Test Arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

The evidence to date supporting the association between treatment with GLP-1 agonists and diabetes remission after metabolic surgery is based on retrospective studies.

This study is a 2:1 randomized, blinded, parallel, prospective placebo-controlled trial with a standardized treatment approach in order to establish the role of GLP-1 in remission of diabetes after metabolic surgery.

The preoperative program for Metabolic Surgery involves multidisciplinary health evaluation and care, as well as patient education lasting approximately 6 months.

After bariatric surgery, patients will continue in the study for 2 years and glycemic control will be managed according to the current standard of care for perioperative glucose control.

Who Took Part

3 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Candidates for Roux-en-Y Gastric Bypass Surgery with an established diagnosis of Type 2 diabetes requiring insulin treatment for glycemic control. Ability to provide informed consent before any trial-related activities.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: prior metabolic surgery procedure; use of glp-1 analogues for diabetes treatment at the time of recruitment; known or suspected allergy to semaglutide or the excipients in semaglutide, or related products.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

The Semaglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Semaglutide was given.

Those kept unaware of assignments: investigator.

It started in 2021-08-25 with completion listed for 2022-07-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: RATE OF PARTIAL REMISSION OF DIABETES (time frame: 11 months).

It also tracked 1 secondary outcome, for example RATE OF COMPLETE REMISSION OF DIABETES.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 3 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.