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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Liraglutide and Peripheral Artery Disease

Short name STARDUST

NCTNCT04881110 (opens ClinicalTrials.gov in a new tab)Other id2_0401_2021
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
University of Campania Luigi Vanvitelli · Other
Design
Randomized · Single masking
Countries
1 country

Italy

Start
1 Feb 2021
Primary completion
31 Dec 2022
Completion
31 Dec 2022
First posted
11 May 2021
Last update posted
3 Mar 2025
Conditions
Type 2 Diabetes · Peripheral Arterial Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 4

    STARDUST

    NCT04881110

    1 Feb 2021 to 31 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • ControlOther

Arms2

  • Experimental

    Liraglutide group

    Patients in this arm will receive liraglutide, according to the current clinical practice.

  • Other

    Control group

    Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Peripheral Transcutaneous Oxygen Pressure

    Time frame · 6 months

    Registry description

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

Secondary outcomes(16)

  1. HbA1c Glucose Control

    Time frame · 6 months

    Registry description

    HbA1c values after 6 months

  2. Glucose Control

    Time frame · 6 months

    Registry description

    fasting glucose differences between groups

  3. Weight Change

    Time frame · 6 months

    Registry description

    Weight value at 6 months minus value at baseline

  4. BMI Change

    Time frame · 6 months

    Registry description

    BMI value at 6 months minus value at baseline

  5. Waist Circumference Change

    Time frame · 6 months

    Registry description

    Waist circumference value at 6 months minus value at baseline

  6. Systolic Blood Pressure Change

    Time frame · 6 months

    Registry description

    systolic blood pressure value at 6 months minus value at baseline

  7. Lipid Profile

    Time frame · 6 months

    Registry description

    total cholesterol after 6 months

  8. C-reactive Protein (CRP) Change

    Time frame · 6 months

    Registry description

    CRP value at 6 months minus value at baseline

  9. Renal Function

    Time frame · 6 months

    Registry description

    creatinine levels after 6 months

  10. Estimated Glomerular Filtration Rate

    Time frame · 6 months

    Registry description

    estimated glomerular filtration rate after 6 months

  11. Angiogenesis

    Time frame · 6 months

    Registry description

    vascular endothelial growth factor (VEGF) after 6 months

  12. Ankle-brachial Index (ABI) Change

    Time frame · 6 months

    Registry description

    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.

  13. Sexual Hormonal Profile

    Time frame · 6 months

    Registry description

    Sexual hormone binding protein after 6 months

  14. Male Sexual Function

    Time frame · 6 months

    Registry description

    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).

  15. Female Sexual Function

    Time frame · 6 months

    Registry description

    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).

  16. 6-minute Walking Test

    Time frame · 6 months

    Registry description

    6-minutes walking distance after 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

Peripheral Transcutaneous Oxygen Pressure

GroupValue (mmHg)Spread
Liraglutide Group54.25.9
Control Group43.44.8
Secondary and other outcome results(7)
Secondary outcomeMean· 6 months

HbA1c Glucose Control

GroupValue (percentage of HbA1c)Spread
Liraglutide Group6.70.7
Control Group6.80.8
Secondary outcomeMedian· 6 months

Glucose Control

GroupValue (mg/dL)
Liraglutide Group118.5
Control Group117
Secondary outcomeMean· 6 months

Weight Change

GroupValue (Kg)Spread
Liraglutide Group78.514.4
Control Group80.712.5
Secondary outcomeMean· 6 months

BMI Change

GroupValue (Kg/m2)Spread
Liraglutide Group28.74
Control Group27.74.4
Secondary outcomeMean· 6 months

Waist Circumference Change

GroupValue (cm)Spread
Liraglutide Group108.910.3
Control Group104.111.6
Secondary outcomeMedian· 6 months

Systolic Blood Pressure Change

GroupValue (mmHg)
Liraglutide Group130
Control Group130
Secondary outcomeMean· 6 months

Lipid Profile

GroupValue (mg/dL)Spread
Liraglutide Group142.340.6
Control Group158.855.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide GroupPatients in this arm will receive liraglutide, according to the current clinical practice. Liraglutide: 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.0 / 270 / 270 / 27
Control GroupPatients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors. Control: 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.0 / 280 / 280 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2024

Corrected

Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial.

Caruso et al. 2024JAMA network opencited by 55

PMID 38470420PMC10933706DOI 10.1001/jamanetworkopen.2024.1545PUB-38470420

CC BY
Download PDFRead the notice

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultCaruso 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. PMID 36812501

Eligibility

Who could join, as posted.

Sex
All
Age
from 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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