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Type 2 DiabetesPhase 4STARDUSTNCT04881110

Liraglutide and Peripheral Artery Disease

A Phase 4 study testing Liraglutide in people with Type 2 Diabetes and Peripheral Arterial Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

STARDUST is an open-label, two-arm randomized controlled trial, aimed at evaluating the effects of liraglutide on peripheral perfusion, as compared with the aggressive treatment of cardio-metabolic risk factors, in people with type 2 diabetes and peripheral artery disease. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Type 2 Diabetes, Peripheral Arterial Disease
What is being tested?
Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
1 Feb 2021to 31 Dec 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli

    Naples, 80138

Other trials in Italy

About this study

Official title: 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

STARDUST is an open-label, two-arm randomized controlled trial, aimed at evaluating the effects of liraglutide on peripheral perfusion, as compared with the aggressive treatment of cardio-metabolic risk factors, in people with type 2 diabetes and peripheral artery disease. The potential benefits for participants in the study include the possibility of improving peripheral perfusion with drugs that have been evaluated as effective in controlling diabetes and safe and protective for cardiovascular health.

The primary outcome of the study is the change of peripheral transcutaneous oxygen tension between groups at three and six months. Participants in the study will be followed for 6 months in order to evaluate the effects of liraglutide and the change of other secondary outcomes.

Read the detailed description

An 18-month extension of the follow-up will be performed for all the study population, according to guidelines and good clinical practice. The follow-up will include the glyco-metabolic parameters and the main cardiovascular risk factors, including TcPO2 assessment.

Data from this extended observation will be collected for additional analyses (mostly regarding the durability of the effects). Individuals who will be lost during follow-up and/or discontinue or modify the glucose-lowering treatment will be excluded from the analyses.

Being tested
Liraglutide, Control
Keywords
Type 2 diabetes, Liraglutide, Transcutaneous Oxygen Tension, Peripheral arterial disease, Inflammation, Angiogenesis, Endothelial Dysfunction, Diabetic microvascular complications
Medical subject headings
Diabetes Mellitus, Type 2, Peripheral Arterial Disease, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Intervention group

    Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.

  • ControlOther

    Also called Control group

    Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.

Study groups in NCT04881110
Study groupRoleWhat they receive
Liraglutide groupExperimentalPatients in this arm will receive liraglutide, according to the current clinical practice.
Receives: Drug: Liraglutide
Control groupOtherPatients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral Transcutaneous Oxygen Pressure

    Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months

    Measured: 6 months

Secondary outcomes (16)

  1. HbA1c Glucose Control

    HbA1c values after 6 months

    Measured: 6 months

  2. Glucose Control

    fasting glucose differences between groups

    Measured: 6 months

  3. Weight Change

    Weight value at 6 months minus value at baseline

    Measured: 6 months

  4. BMI Change

    BMI value at 6 months minus value at baseline

    Measured: 6 months

  5. Waist Circumference Change

    Waist circumference value at 6 months minus value at baseline

    Measured: 6 months

  6. Systolic Blood Pressure Change

    systolic blood pressure value at 6 months minus value at baseline

    Measured: 6 months

  7. Lipid Profile

    total cholesterol after 6 months

    Measured: 6 months

  8. C-reactive Protein (CRP) Change

    CRP value at 6 months minus value at baseline

    Measured: 6 months

  9. Renal Function

    creatinine levels after 6 months

    Measured: 6 months

  10. Estimated Glomerular Filtration Rate

    estimated glomerular filtration rate after 6 months

    Measured: 6 months

  11. Angiogenesis

    vascular endothelial growth factor (VEGF) after 6 months

    Measured: 6 months

  12. Ankle-brachial Index (ABI) Change

    ABI value after 6 months minus value at baseline ABI evaluation was obtained dividing the leg systolic pressure by the arm systolic pressure, both detected through a doppler probe and a sphygmomanometer.

    Normal ABI ranges from 1.0 to 1.4. ABI values above 1.4 suggest a noncompressible calcified vessel. ABI value below 0.9 is considered diagnostic of PAD.

    Measured: 6 months

  13. Sexual Hormonal Profile

    Sexual hormone binding protein after 6 months

    Measured: 6 months

  14. Male Sexual Function

    Erectile function (IIEF-5) score at 6 months Male patients will perform a self-assessment test (IIEF-5) of their erectile function and overall satisfaction with sexual life, referring to the previous 6 months.

    Erectile dysfunction (ED) will be classified based on the total questionnaire score. The highest score available is 25, the lowest is 0. Any score ranging from 25 and 22 refers to the absence of ED.

    Any score ≤ 21 will indicate the presence of ED [mild (score 21-17), mild-moderate (score 16 -12), moderate (score 11-8) and severe (score 7-1)].

    The IIEF-5 questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).

    Measured: 6 months

  15. Female Sexual Function

    Female sexual function (FSFI) after 6 months Female sexual function will be studied through the FSFI questionnaire which assesses sexual activity over the past 4 weeks and includes 19 questions. The questionnaire will investigate six distinct domains (sexual desire, arousal, lubrication, orgasm, satisfaction and pain), and provide a total score indicative of global sexual function.

    Points are assigned for each answer (from 1 to 5 for 1-2 questions, from 0 to 5 for 3-19): the sum of the scores for each domain is multiplied by a domain factor (desire 0.6, arousal 0.3, lubrication 0.3 orgasm 0.4, satisfaction 0.4, pain 0.4). The six domain scores are added up, and the total score may vary from 2.0 to 36.0 points.

    A total FSFI score < 26.55 will be used to classify the presence of female sexual dysfunction. The FSFI questionnaire will be administered at visit 2 (week 0) and at the end of the study (week 24).

    Measured: 6 months

  16. 6-minute Walking Test

    6-minutes walking distance after 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start1 Feb 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881110
Sponsor's protocol ID
2_0401_2021
Acronym
STARDUST
Status last verified
Feb 2025
First submitted
6 May 2021
Last updated
3 Mar 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Caruso P, Maiorino MI, Bellastella G, Esposito K, Giugliano D. Pleiotropic effects of GLP-1 receptor agonists on peripheral artery disease: Is there any hope? Diabetes Metab Res Rev. 2023 Oct;39(7):e3627. doi: 10.1002/dmrr.3627. Epub 2023 Mar 4. No abstract available.

    PubMed 36812501

  • Caruso P, Maiorino MI, Longo M, Porcellini C, Matrone R, Digitale Selvaggio L, Gicchino M, Carbone C, Scappaticcio L, Bellastella G, Giugliano D, Esposito K. Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e241545. doi: 10.1001/jamanetworkopen.2024.1545.

    PubMed 38470420

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide in people with Type 2 Diabetes and Peripheral Arterial Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

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 5 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 3 Mar 2025. 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 Italy. 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?

Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Peripheral Transcutaneous Oxygen Pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881110, which also lists 2 linked publications.

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 3 Mar 2025.

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