Novel Therapeutics and Endothelial Dysfunction in T1DM Patients (ENDIS)

General and Teaching Hospital Celje

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Incretins; Glucose Excursions; Biomarkers; Endothelial Dysfunction; SGLT 2 Inhibitors; FMD; FPF; Endothelial Progenitor Cells; Arterial Stiffness

Treatments: Drug: Semaglutide Pen Injector [Ozempic]; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05857085

0120-63-2020

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

GLP 1 agonist

Active Comparator group

Description:

semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)

Treatment:

Drug: Semaglutide Pen Injector [Ozempic]

SGLT 2 inhibitor

Active Comparator group

Description:

empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)

Treatment:

Drug: Empagliflozin 10 MG

comparator

No Intervention group

Description:

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