ENDIS

CompletedPhase 4

Novel Therapeutics and Endothelial Dysfunction in T1DM Patients

Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients

Lead sponsor

General and Teaching Hospital Celje

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤9%

Primary endpoints

•Evaluation of endothelial function by flow mediated dilation (FMD) of brachial•Evaluation of endothelial function by strain gauge plethysmography as change•Evaluation of arterial stiffness with peak wave velocity ( PWV)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05857085

Org study ID0120-63-2020

Timeline

Milestones

Study start2021-12-15actual

Primary completion2022-03-10actual

Study completion2023-04-20actual

Study first posted2023-05-12actual

Last update posted2023-05-12actual

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•T1DM

•HbA1C<=9%

•prone to CGM system

•20 - 70 years

Exclusion criteria

•HbA1C >9%,

•BMI<22,

•pregnancy or lactation,

•known hypersensitivity to study drug,

•malignant disease ( excluded >5 years disease free, bazocellular or planocellular ca of skin),

•liver cirrhosis child C,

•eGFR<60 ml/min,

•chronic inflammatory disease,

•proliferative diabetic rethinopathy,

•MEN or medullary thyroid cancer in familly,

•concomitant drugs with influence on glycemia and antiinflammatory influence (corticosteroids, immunosupresive therapy),

•Major cardiovascular event last 2 months ( stroke, MI)

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Weight & body composition

1 endpoint

Other/protocol endpoint

body impedance measurements

Time frame:12 weeks

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Other/protocol endpoint

changes of glycemia endpoints glucovariability/time in range

Time frame:2 weeks

CGM time-in-range

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints

Primary/protocol endpoint

evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery

Time frame:12 weeks

percent change from baseline, improvement

Primary/protocol endpoint

evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow

Time frame:12 weeks

change from baseline, improvement

Primary/protocol endpoint

evaluation of arterial stiffness with peak wave velocity ( PWV)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

evaluation of change in inflammatory biomarkers

Time frame:12 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

evaluation of change in biomarkers of endothelial dysfunction

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

evaluation of endothelial progenitor cells EPC count

Time frame:12 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.