Endothelial DysfunctionPhase 4ENDISNCT05857085
Novel Therapeutics and Endothelial Dysfunction in T1DM Patients
A Phase 4 study testing Semaglutide Pen Injector [Ozempic] and Empagliflozin 10 MG in people with Endothelial Dysfunction and Diabetes Mellitus, Type 1, run by General and Teaching Hospital Celje at 1 site in Slovenia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Endothelial Dysfunction, Diabetes Mellitus, Type 1, Biomarkers
- What is being tested?
- Semaglutide Pen Injector [Ozempic] and Empagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Dec 2021to 20 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1DM
- HbA1C<=9%
- prone to CGM system
- 20 - 70 years
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients
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.
- Conditions
- Endothelial Dysfunction, Diabetes Mellitus, Type 1, Biomarkers, Endothelial Progenitor Cells, SGLT 2 Inhibitors, Incretins
- Being tested
- Semaglutide Pen Injector [Ozempic], Empagliflozin 10 MG
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen Injector [Ozempic]Drug
GLP 1 agonist
Empagliflozin 10 MGDrug
SGLT 2 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| GLP 1 agonist | Active comparator | semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII) Receives: Drug: Semaglutide Pen Injector [Ozempic] |
| SGLT 2 inhibitor | Active comparator | empagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system) Receives: Drug: Empagliflozin 10 MG |
| comparator | No intervention | continuing treatment only with insulin sheme (MDI or CII or hybride system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention
Measured: 12 weeks
evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow
changes in tissue perfusion (ml/100 ml of tissue/min) measured with strange gauge plethysmography as formarm blood flow before and after postishemic reactive hyperemija comparing two therapeutic groups and control group before and after intervention
Measured: 12 weeks
evaluation of arterial stiffness with peak wave velocity ( PWV)
measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention
Measured: 12 weeks
Secondary outcomes (3)
evaluation of change in inflammatory biomarkers
change of hs CRF, Il6 after treatment comparing two therapeutic groups and control
Measured: 12 weeks
evaluation of change in biomarkers of endothelial dysfunction
change in s-VCAM, s-ICAM values before and after intervention - comparing two therapeutic groups and control
Measured: 12 weeks
evaluation of endothelial progenitor cells EPC count
change in count of endothelial progenitor cells CD 34*, 133+ as endothelial function markers before and after intervention - comparing two therapeutic groups and control
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start15 Dec 2021
- Primary completion10 Mar 2022
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- General and Teaching Hospital Celje
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrej Janez, prof PhD, Study chair, General and teaching hospital Celje and UKC Ljubljana/Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857085
- Sponsor's protocol ID
- 0120-63-2020
- Acronym
- ENDIS
- Status last verified
- May 2023
- First submitted
- 29 Sep 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Additional Treatment With Empagliflozin or Semaglutide on Endothelial Function and Other Clinical Parameters and Biomarkers in T1DM Patients
- ClinicalTrials.gov ID
- NCT05857085
- Acronym / sponsor ID
- ENDIS / 0120-63-2020
- Conditions
- Endothelial Dysfunction, Diabetes Mellitus, Type 1, Biomarkers, Endothelial Progenitor Cells, SGLT 2 Inhibitors, Incretins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- General and Teaching Hospital CeljeUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
| Arm | Type | Receives |
|---|---|---|
| GLP 1 agonist | Active comparator | Drug: Semaglutide Pen Injector [Ozempic]semaglutide in titrating doses 0,25 to 1,0 mg - duration of treatment12 weeks adding to insulin sheme (MDI or CII) |
| SGLT 2 inhibitor | Active comparator | Drug: Empagliflozin 10 MGempagliflozin 25 mg - duration of treatment 12 weeks adding to insulin sheme (MDI or CII or hybride system) |
| comparator | No intervention | –continuing treatment only with insulin sheme (MDI or CII or hybride system) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T1DM
- HbA1C<=9%
- prone to CGM system
- 20 - 70 years
Key exclusion criteria (12 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen Injector [Ozempic]GLP 1 agonist | Drug | GLP 1 agonist |
| Empagliflozin 10 MGSGLT 2 inhibitor | Drug | SGLT 2 inhibitor |
Primary outcome
evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery
Time frame: 12 weeks
measurement of dilation of brachial artery (in %) before and after postishemic hyperemia comparing two therapeutic groups and control group before and after intervention
evaluation of endothelial function by strain gauge plethysmography as change in forearm blood flow
Time frame: 12 weeks
changes in tissue perfusion (ml/100 ml of tissue/min) measured with strange gauge plethysmography as formarm blood flow before and after postishemic reactive hyperemija comparing two therapeutic groups and control group before and after intervention
evaluation of arterial stiffness with peak wave velocity ( PWV)
Time frame: 12 weeks
measurements of the velocity (m/s) at which arterial blood pressure pulses propagate - comparing two therapeutic groups and control group before and after intervention
3 secondary outcomes
evaluation of change in inflammatory biomarkers
Time frame: 12 weeks
evaluation of change in biomarkers of endothelial dysfunction
Time frame: 12 weeks
evaluation of endothelial progenitor cells EPC count
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Janez, prof PhD study chair
General and teaching hospital Celje and UKC Ljubljana/Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide Pen Injector [Ozempic] and Empagliflozin 10 MG in people with Endothelial Dysfunction and Diabetes Mellitus, Type 1, run by General and Teaching Hospital Celje at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of endothelial function by flow mediated dilation (FMD) of brachial artery (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.