GLP-1 Peptide Atlas, by Delfa

Recruiting

The Cardiovascular Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination

The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk

Lead sponsor

University of Athens

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

Enrollment

240

estimated

Study population

Cardiovascular disease, Heart failure, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Comparison of Global Longitudinal Strain (GLS) difference among treatment groups

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 IDNCT03878706

Org study ID2790/03-11-2017

Timeline

Milestones

Study start2017-11-03actual

Study first posted2019-03-18actual

Last update posted2026-03-13actual

Primary completion2026-12-31estimated

Study completion2027-06-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide

Study populations

Who this study enrolls

Cardiovascular diseaseHeart failureType 2 diabetes

Eligibility

Who can enroll

Minimum age45 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Sampling methodProbability sample

Study population text

240 individuals (60 subjects in each group)

Inclusion criteria

•Subject has type 2 diabetes mellitus

•Subject has high or very high cardiovascular risk

•Subject has heart failure with preserved ejection fraction

Exclusion criteria

•Subject has type 1 diabetes mellitus

•Subject has kidney disease

•Subject has retinopathy

Endpoints (16)

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

Other (unclassified)

Cardiometabolic biomarkers

Heart failure

Cardiovascular outcomes

MASH / liver

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

Comparison of non-fatal cardiovascular events' incidence between the treatment groups

Time frame:6 years

4-point MACE

composite event, event

componentsNon-fatal MI, Ischemic stroke, Heart-failure hospitalization

MASH / liver

1 endpoint

Secondary/protocol endpoint/low confidence

Comparison of liver steatosis level between treatment groups

Time frame:12 months

change from baseline, improvement

Heart failure

3 endpoints

Primary/protocol endpoint/low confidence

Comparison of Global Longitudinal Strain (GLS) difference among treatment groups.

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Comparison of cardiac biomarkers differences among treatment groups.

Time frame:12 months

NT-proBNP, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Comparison of cardiac biomarkers differences between coronary artery disease patients and non-coronary artery disease patients in each study group.

Time frame:12 months

NT-proBNP, change

descriptive

componentsNT-proBNP, change

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Comparison of arterial stiffness markers difference among treatment groups.

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Comparison of wave reflection markers difference among treatment groups

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Comparison of central aortic blood pressure differences among treatment groups

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Comparison of endothelial glycocalyx thickness difference among treatment groups

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Comparison of arterial stiffness difference between coronary artery disease patients and non-coronary artery disease patients in each study group.

Time frame:12 months

descriptive

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Comparison of oxidative stress and endothelial function biomarkers differences among treatment groups

Time frame:12 months

change from baseline, improvement

componentsmalondialdehyde, protein carbonyls, vcam 1, icam 1, thrombomodulin, nitrites nitrates

Secondary/protocol endpoint/low confidence

Comparison of left ventricular myocardial function difference between coronary artery disease patients and non-coronary artery disease patients in each study group.

Time frame:12 months

descriptive

Secondary/protocol endpoint/low confidence

Comparison of endothelial glycocalyx thickness difference between coronary artery disease patients and non-coronary artery disease patients in each study group.

Time frame:12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Comparison of oxidative stress and endothelial function biomarkers differences between coronary artery disease patients and non-coronary artery disease patients in each study group.

Time frame:12 months

descriptive

Secondary/protocol endpoint/low confidence

Comparison of carotid atherosclerotic markers between treatment groups

Time frame:12 months

descriptive

Secondary/protocol endpoint/low confidence

Comparison of cost analysis for the four treatment groups

Time frame:6 years

descriptive

Publications (26)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effects of Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter-2 Inhibitors, and Their Combination on Neurohumoral and Mitochondrial Activation in Patients With Diabetes.
Journal of the American Heart Association2025 Mar 4PMID40008510doi:10.1161/JAHA.124.039129via clinicaltrials gov reference derived + pubmed nct search
Effects of Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter-2 Inhibitors, and Their Combination on Endothelial Glycocalyx, Arterial Function, and Myocardial Work Index in Patients With Type 2 Diabetes Mellitus After 12-Month Treatment.
Journal of the American Heart Association2020 May 5PMID32326806doi:10.1161/JAHA.119.015716via clinicaltrials gov reference derived + pubmed nct search
How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).
European journal of heart failure2020 Mar (month)PMID32133741doi:10.1002/ejhf.1741via CT.gov reference
Early detection of left ventricular dysfunction in first-degree relatives of diabetic patients by myocardial deformation imaging: The role of endothelial glycocalyx damage.
International journal of cardiology2017 Apr 15PMID28096045doi:10.1016/j.ijcard.2017.01.056via CT.gov reference
The interplay between renin-angiotensin system activation, abnormal myocardial deformation and neurohumoral activation in hypertensive heart disease: a speckle tracking echocardiography study.
The international journal of cardiovascular imaging2017 Mar (month)PMID27787699doi:10.1007/s10554-016-1010-1via CT.gov reference
Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial.
The lancet. Diabetes & endocrinology2016 Dec (month)PMID27651331doi:10.1016/S2213-8587(16)30267-4via CT.gov reference
Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.
The New England journal of medicine2016 Jul 28PMID27299675doi:10.1056/NEJMoa1515920via CT.gov reference
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
The New England journal of medicine2016 Jul 28PMID27295427doi:10.1056/NEJMoa1603827via CT.gov reference
7. Approaches to Glycemic Treatment.
Diabetes care2016 Jan (month)PMID26696682doi:10.2337/dc16-S010via CT.gov reference
Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.
The New England journal of medicine2015 Nov 26PMID26378978doi:10.1056/NEJMoa1504720via CT.gov reference
Energy Balance After Sodium-Glucose Cotransporter 2 Inhibition.
Diabetes care2015 Sep (month)PMID26180105doi:10.2337/dc15-0355via CT.gov reference
American association of clinical endocrinologists and american college of endocrinology - clinical practice guidelines for developing a diabetes mellitus comprehensive care plan - 2015.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2015 Apr (month)PMID25869408doi:10.4158/EP15672.GLvia CT.gov reference
Similarities in coronary function and myocardial deformation between psoriasis and coronary artery disease: the role of oxidative stress and inflammation.
The Canadian journal of cardiology2015 Mar (month)PMID25660150doi:10.1016/j.cjca.2014.11.002via CT.gov reference
User's guide to mechanism of action and clinical use of GLP-1 receptor agonists.
Postgraduate medicine2015 (year)PMID26371721doi:10.1080/00325481.2015.1090295via CT.gov reference
Effects of glucagon-like peptide 1 on appetite and body weight: focus on the CNS.
The Journal of endocrinology2014 Apr (month)PMID24323912doi:10.1530/JOE-13-0414via CT.gov reference
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
Diabetes care2014 (year)PMID24144654doi:10.2337/dc13-0467via CT.gov reference
Rapid tachyphylaxis of the glucagon-like peptide 1-induced deceleration of gastric emptying in humans.
Diabetes2011 May (month)PMID21430088doi:10.2337/db10-0474via CT.gov reference
Incremental predictive value of carotid intima-media thickness to arterial stiffness for impaired coronary flow reserve in untreated hypertensives.
Hypertension research : official journal of the Japanese Society of Hypertension2010 Apr (month)PMID20139923doi:10.1038/hr.2010.2via CT.gov reference
Incremental value of pulse wave velocity in the determination of coronary microcirculatory dysfunction in never-treated patients with essential hypertension.
American journal of hypertension2008 Jul (month)PMID18497732doi:10.1038/ajh.2008.172via CT.gov reference
Aortic pulse wave velocity predicts cardiovascular mortality in subjects >70 years of age.
Arteriosclerosis, thrombosis, and vascular biology2001 Dec (month)PMID11742883doi:10.1161/hq1201.100226via CT.gov reference
Cardiovascular risk assessment using pulse pressure in the first national health and nutrition examination survey (NHANES I).
Hypertension (Dallas, Tex. : 1979)2001 Oct (month)PMID11641288doi:10.1161/hy1001.092966via CT.gov reference
Aortic stiffness is an independent predictor of all-cause and cardiovascular mortality in hypertensive patients.
Hypertension (Dallas, Tex. : 1979)2001 May (month)PMID11358934doi:10.1161/01.hyp.37.5.1236via CT.gov reference
Is pulse pressure useful in predicting risk for coronary heart Disease? The Framingham heart study.
Circulation1999 Jul 27PMID10421594doi:10.1161/01.cir.100.4.354via CT.gov reference
Increased pulse pressure and risk of heart failure in the elderly.
JAMA1999 Feb 17PMID10029125doi:10.1001/jama.281.7.634via CT.gov reference
Effects of age and aerobic capacity on arterial stiffness in healthy adults.
Circulation1993 Oct (month)PMID8403292doi:10.1161/01.cir.88.4.1456via CT.gov reference
Effects of aging on arterial distensibility in populations with high and low prevalence of hypertension: comparison between urban and rural communities in China.
Circulation1985 Feb (month)PMID3965165doi:10.1161/01.cir.71.2.202via CT.gov reference

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.