STARDUST

CompletedPhase 4Results posted

Liraglutide and Peripheral Artery Disease

Effects of the Glucagon Like-peptide 1 (GLP-1) Receptor Agonist Liraglutide on Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: a Randomized Controlled Trial

Lead sponsor

University of Campania Luigi Vanvitelli

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-8%

Primary endpoint

•Peripheral Transcutaneous Oxygen Pressure

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 IDNCT04881110

Org study ID2_0401_2021

Timeline

Milestones

Study start2021-02-01actual

Study first posted2021-05-11actual

Primary completion2022-12-31actual

Study completion2022-12-31actual

Last update posted2025-03-03actual

Results first posted2025-03-03actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•diagnosis of type 2 diabetes within at least 6 months

•peripheral arterial disease documented within al least 1 year by doppler ultrasound, angio-CT or arteriography

•peripheral transcutaneous oxygen pressure between 30 and 49 mmHg on anterior and/or posterior tibial arteries

•Hba1c 6,5-8%

•treatment of diabetes with metformin, insulin and/or sulfonylurea

Exclusion criteria

•diagnosis of type 1 diabetes

•current treatment with GLP-1 receptor agonists (GLP-1RAs) or dipeptidyl peptidase -4 (DPP-4) inhibitors

•GLP-1RAs allergy or intolerance

•participation to other clinical studies

•history of pancreatitis, thyroid disease, diabetic gastroparesis or inflammatory bowel disease

•current or planned pregnancy

•acute myocardial infarction and/or acute cerebrovascular disease within 14 days from the screening visit

•planned revascularization procedure

•renal function with estimated glomerular filtration rate (eGFR) below 15 ml/min

•history of cancer and/or oncological treatment within 5 years from the screening visit

•current treatment with corticosteroids

•psychiatric or other clinical conditions which may interfere with the study

Endpoints (34)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Renal / kidney

Patient-reported / QoL

Other clinical outcomes

Heart failure

Other (unclassified)

Weight & body composition

6 endpoints

Secondary/registry result

Weight Change

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Liraglutide Group	78.5	—
Control Group	80.7	—

Mean Difference (Final Values)-1.195% CI-3.6 – 1.2p0.33t-test, 2 sided

Secondary/registry result

BMI Change

Time frame:6 months

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kg/m2	95% CI
Liraglutide Group	28.7	—
Control Group	27.7	—

Mean Difference (Final Values)-0.795% CI-1.7 – 0.1p0.10t-test, 2 sided

Secondary/registry result

Waist Circumference Change

Time frame:6 months

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Liraglutide Group	108.9	—
Control Group	104.1	—

Mean Difference (Final Values)0.3695% CI-2.8 – 3.5p0.81t-test, 2 sided

Secondary/protocol endpoint

Weight Change

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

BMI Change

Time frame:6 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist Circumference Change

Time frame:6 months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/registry result

HbA1c Glucose Control

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
Liraglutide Group	6.7	—
Control Group	6.8	—

Mean Difference (Final Values)-0.495% CI-0.8 – 0.01p0.06t-test, 2 sided

Secondary/registry result

Glucose Control

Time frame:6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (median), mg/dL	95% CI
Liraglutide Group	118.5	91 – 132.5
Control Group	117	98 – 122

Mean Difference (Final Values)-3.495% CI-14.3 – 7.4p0.52t-test, 2 sided

Secondary/protocol endpoint

HbA1c Glucose Control

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Glucose Control

Time frame:6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Heart failure

2 endpoints

Secondary/registry result

6-minute Walking Test

Time frame:6 months

6-minute walk distance

descriptive, improvement

Posted result

Group	Value (mean), meters	95% CI
Liraglutide Group	364	—
Control Group	340	—

Mean Difference (Final Values)25.195% CI21.8 – 28.3p<0.001t-test, 2 sided

Secondary/protocol endpoint

6-minute Walking Test

Time frame:6 months

6-minute walk distance

change from baseline, improvement

Renal / kidney

4 endpoints

Secondary/registry result

Renal Function

Time frame:6 months

change from baseline, improvement

LOINC 2160-0

Posted result

Group	Value (median), mg/dL	95% CI
Liraglutide Group	1	0.8 – 1.2
Control Group	0.8	0.8 – 1

Mean Difference (Final Values)0.195% CI-0.04 – 0.3p0.12t-test, 2 sided

Secondary/registry result

Estimated Glomerular Filtration Rate

Time frame:6 months

eGFR, change

change from baseline, improvement

Posted result

Group	Value (mean), mL/min/1.73 m^2	95% CI
Liraglutide Group	71	—
Control Group	74.7	—

Mean Difference (Final Values)-3.0995% CI-8.5 – 2.3p0.25t-test, 2 sided

Secondary/protocol endpoint

Renal Function

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Estimated Glomerular Filtration Rate

Time frame:6 months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

Systolic Blood Pressure Change

Time frame:6 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (median), mmHg	95% CI
Liraglutide Group	130	120 – 130
Control Group	130	125 – 140

Mean Difference (Final Values)-0.00395% CI-5.8 – 5.8p0.99t-test, 2 sided

Secondary/registry result

Lipid Profile

Time frame:6 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide Group	142.3	—
Control Group	158.8	—

Mean Difference (Final Values)-4.895% CI-32.6 – 22.9p0.72t-test, 2 sided

Secondary/registry result

C-reactive Protein (CRP) Change

Time frame:6 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide Group	0.5	—
Control Group	0.8	—

Mean Difference (Final Values)-0.495% CI-0.7 – -0.07p0.02t-test, 2 sided

Secondary/registry result

Angiogenesis

Time frame:6 months

concentration, descriptive

Posted result

Group	Value (median), pg/mL	95% CI
Liraglutide Group	124	77.5 – 188
Control Group	68.4	52.2 – 80.8

Mean Difference (Final Values)87.495% CI59.9 – 115.1p<0.001t-test, 2 sided

Secondary/protocol endpoint

Systolic Blood Pressure Change

Time frame:6 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Lipid Profile

Time frame:6 months

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

C-reactive Protein (CRP) Change

Time frame:6 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Ankle-brachial Index (ABI) Change

Time frame:6 months

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Male Sexual Function

Time frame:6 months

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	95% CI
Liraglutide Group	12.4	—
Control Group	12.5	—

Mean Difference (Final Values)1.295% CI-0.09 – 2.6p0.06t-test, 2 sided

Secondary/registry result

Female Sexual Function

Time frame:6 months

descriptive, improvement

Posted result

Group	Value (mean), score on a scale	95% CI
Liraglutide Group	20.4	—
Control Group	21.2	—

Secondary/protocol endpoint

Male Sexual Function

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Female Sexual Function

Time frame:6 months

descriptive, improvement

Other clinical outcomes

4 endpoints

Primary/registry result/low confidence

Peripheral Transcutaneous Oxygen Pressure

Time frame:6 months

descriptive

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide Group	54.2	—
Control Group	43.4	—

Mean Difference (Final Values)11.295% CI8.0 – 14.5p<0.001t-test, 2 sided

Risk Ratio (RR)1.9195% CI1.26 – 2.90p<0.001Chi-squared

Primary/protocol endpoint

Peripheral Transcutaneous Oxygen Pressure

Time frame:6 months

change from baseline, improvement

Secondary/registry result/low confidence

Sexual Hormonal Profile

Time frame:6 months

descriptive

Posted result

Group	Value (median), nmol/L	95% CI
Liraglutide Group	45	34.1 – 51.7
Control Group	49.5	44.5 – 66.2

Mean Difference (Final Values)8.795% CI-0.6 – 18.1p0.06t-test, 2 sided

Secondary/protocol endpoint

Sexual Hormonal Profile

Time frame:6 months

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/registry result/low confidence

Ankle-brachial Index (ABI) Change

Time frame:6 months

change from baseline, improvement

Posted result

Group	Value (median), ratio	95% CI
Liraglutide Group	0.9	0.9 – 1
Control Group	1	0.9 – 1.1

Mean Difference (Final Values)-0.0395% CI-0.09 – 0.01p0.18t-test, 2 sided

Secondary/protocol endpoint/low confidence

Angiogenesis

Time frame:6 months

change from baseline, improvement

Publications (2)

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

Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial.
JAMA network open2024 Mar 4PMID38470420doi:10.1001/jamanetworkopen.2024.1545via clinicaltrials gov reference derived + pubmed nct search
Pleiotropic effects of GLP-1 receptor agonists on peripheral artery disease: Is there any hope?
Diabetes/metabolism research and reviews2023 Oct (month)PMID36812501doi:10.1002/dmrr.3627via 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 tableClinicalTrials.gov results section

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.