GLP-1 RA for Stage 1 Type 1 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

This study seeks to evaluate the hormone responses of insulin, c-peptide, glucagon, and incretins to semaglutide, a GLP-1 receptor agonist therapy, in individuals with stage 1 type 1 diabetes.

The goal of this study is to see if semaglutide can protect beta cell function in this group of people and delay the progression to stage 2 type 1 diabetes.

It had two arms (groups): Semaglutide or Placebo Treatment (experimental) and Placebo (placebo comparator).

Randomized to placebo or semaglutide.

The registry classes the interventions as drug.

More on the Plan

This study aims to evaluate the effects of semaglutide on pancreatic beta and alpha cell function in individuals with stage 1 type 1 diabetes (T1D).

Despite having euglycemia, individuals with stage 1 T1D may already exhibit loss of the first phase insulin response (FPIR).

Not only do incretins affect beta cells, but they can also inhibit glucagon secretion, potentially attenuating this dysregulated glucagon response.

However, no studies have evaluated the effects of GLP-1 RAs on beta cell function and glucagon secretion in stage 1 type 1 diabetes to date.

Who Took Part

Enrollment: 15 planned participants were the target.

It was open to people of any sex aged from 12 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Stage 1 Type 1 Diabetes.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: history of anaphylaxis or allergies to glp-1 receptor agonists; already on a glp-1 receptor agonist; history of bariatric surgery.

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.

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

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 2027-09-01 with completion listed for 2029-06-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: C-peptide area under the curve (time frame: 12 months). C-peptide area under the curve (AUC) (time frame: 12 months).

It also tracked 2 secondary outcomes, for example Stimulated incretin levels and Glucagon secretion.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 15 people.

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

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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