ADJUnct Semaglutide Treatment in Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Control (placebo comparator).

Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy.

Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy.

The registry classes the interventions as drug.

More on the Plan

After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry.

At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.

Who Took Part

115 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age ≥18 and ≤ 65 years. Patients with clinical diagnosis of T1D diagnosed for at least 12 months. Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months. Willing to use once weekly semaglutide. Willing to share devices (HCL system) data uploads.

The full record lists 10 inclusion and 30 exclusion criteria; among the exclusions: age \<18 years and \>65 years; less than 12 months of insulin treatment; use of unapproved insulin for hcl system. e.g. use of fiasp in the tandem control-iq system.

How the Study Was Run

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

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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-04-11 with completion listed for 2024-08-06.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Change in HbA1c, Change in Mean Glucose, Change in CGM Measured Glycemic Variability (Coefficient of Variation), Change in Weight, Change in BMI (Kg/m2) and Severe Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 115 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, all human trials.