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

0120-63-2020

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.

2021-12-15

2022-03-10

2023-04-20

Completed

Early phase I

90

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2023-05-12