Novel Therapeutics and Endothelial Dysfunction in T1DM Patients
NCT ID: NCT05857085
Last Updated: 2023-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2021-12-15
2023-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GLP 1 agonist
semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII)
Semaglutide Pen Injector [Ozempic]
GLP 1 agonist
SGLT 2 inhibitor
empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system)
Empagliflozin 10 MG
SGLT 2 inhibitor
comparator
continuing treatment only with insulin sheme (MDI or CII or hybride system)
No interventions assigned to this group
Interventions
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Semaglutide Pen Injector [Ozempic]
GLP 1 agonist
Empagliflozin 10 MG
SGLT 2 inhibitor
Eligibility Criteria
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Inclusion Criteria
* HbA1C\<=9%
* prone to CGM system
* 20 - 70 years
Exclusion Criteria
* 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)
20 Years
70 Years
ALL
No
Sponsors
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General and Teaching Hospital Celje
OTHER
Responsible Party
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Principal Investigators
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Andrej Janez, prof PhD
Role: STUDY_CHAIR
General and teaching hospital Celje and UKC Ljubljana/Maribor
Locations
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General Hospital Celje
Celje, , Slovenia
Countries
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Other Identifiers
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0120-63-2020
Identifier Type: -
Identifier Source: org_study_id
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