Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

What Was Tested

The trial (phase 4) is built around Semaglutide.

The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide or empagliflozine) compared to control group in T1DM patients - impact on endothelial function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD 133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.

It had three arms (groups): GLP 1 agonist (active comparator), SGLT 2 inhibitor (active comparator) and comparator (no intervention).

Continuing treatment only with insulin sheme (MDI or CII or hybride system).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to people of any sex aged from 20 years up to 70 years.

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

Examples of who could join: Prone to CGM system. 20 - 70 years.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: pregnancy or lactation,; known hypersensitivity to study drug,; malignant disease ( excluded \>5 years disease free, bazocellular or planocellular ca of skin),.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2021-12-15 with completion listed for 2022-03-10.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery (time frame: 12 weeks). evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow (time frame: 12 weeks). evaluation of arterial stiffness with peak wave velocity ( PWV) (time frame: 12 weeks).

It also tracked 3 secondary outcomes, for example evaluation of change in inflammatory biomarkers, evaluation of change in biomarkers of endothelial dysfunction and evaluation of endothelial progenitor cells EPC count.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 90 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.