GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab

What Was Tested

This registered early phase 1 trial tested Semaglutide.

The meal tests are followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo.

It had four arms (groups): Participants receiving placebo, Stage 2 T1DM participants (placebo comparator), Participants receiving a semaglutide (Rybelsus®), Stage 2 T1DM participants (experimental), Placebo Comparator: Participants receiving placebo, Stage 3 T1DM participants (placebo comparator) and Experimental: Participants receiving a semaglutide (Rybelsus®), Stage 3 T1DM participants (experimental).

Participants receive a placebo orally once before the pre-TZIELD® MMTT. Participants also receive a placebo orally once before one of the post-TZIELD® MMTTs.

Participants receive a placebo orally once before each MMTT.

The registry classes the interventions as drug.

More on the Plan

For early stage 3 T1DM, the researchers aim to determine whether GLP-1Ra can offer similar protective effects in preserving β-cell function and stabilizing glycemic control.

The immediate objective is to investigate the impact of GLP-1Ra's insulinotropic and glucagonostatic effects on dysmetabolism in stage 2 and early stage 3 T1DM.

The rationale for this hypothesis is based on two observations: first, GLP-1Ra combined with immunomodulatory therapy sustains endogenous secretion in response to a mixed meal tolerance test (MMTT) during the first year of stage 3; and second, GLP-1Ras mitigate postprandial hyperglucagonemia in longer-duration T1DM.

To test the hypothesis, studies will be conduct in individuals with stage 2 T1DM treated with teplizumab using a crossover design structured around the following specific aims: Aim 1: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study.

Who Took Part

24 planned participants were the target.

It was open to people of any sex aged from 12 years up to 50 years.

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

Examples of who could join: Age: 12-50 years. BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric). Stage 2 T1DM (i.e., ≥ 2 islet auto-antibodies and:.

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: SBP \> 140 mmHg and DBP \> 100 mmHg; AST or ALT \> 2.5 times ULN; family history of medullary thyroid carcinoma.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2024-06-12 with completion listed for 2027-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study. Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study. Determine the impact of GLP-1Ra on endothelial function in a pilot study (time frame: During the last 30 minutes of each MMTT, between the 210 and 240 timepoints).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Semaglutide in 24 people.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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