Liraglutide and Peripheral Artery Disease

NCT04881110 | Completed Phase 4 Results

• 1 other identifier: 2_0401_2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes; Peripheral Arterial Disease

Keywords

Type 2 diabetes; Liraglutide; Transcutaneous Oxygen Tension; Peripheral arterial disease; Inflammation; Angiogenesis; Endothelial Dysfunction; Diabetic microvascular complications

Outcome Measures

Primary Outcomes (1)

• Peripheral Transcutaneous Oxygen Pressure

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

  6 months

Secondary Outcomes (16)

• HbA1c Glucose Control

  6 months

• Glucose Control

  6 months

• Weight Change

  6 months

• BMI Change

  6 months

• Waist Circumference Change

  6 months

Study Arms (2)

Liraglutide group

EXPERIMENTAL

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

Drug: Liraglutide

Control group

OTHER

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

Other: Control

Interventions

Liraglutide DRUG

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.

Also known as: Intervention group

Liraglutide group

Control OTHER

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.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

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

Napoli, 80138, Italy

Location

Related Publications (2)

• 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.

  PMID: 36812501 RESULT

• 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.

  PMID: 38470420 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Peripheral Arterial Disease; Inflammation

Interventions

Liraglutide; Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Prof. Katherine Esposito, Head of the Division of Endocrinology and Metabolic Diseases
• Organization: University of Campania Luigi Vanvitelli

katherine.esposito@unicampania.it

+390815665031

Study Officials

• Katherine Esposito, MD, PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology and Metabolic Diseases, Head of Unit of Diabetes

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)