Liraglutide and Peripheral Artery Disease (STARDUST)

University of Campania Luigi Vanvitelli

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes; Peripheral Arterial Disease

Treatments: Drug: Liraglutide; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04881110

2_0401_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Liraglutide group

Experimental group

Description:

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

Treatment:

Drug: Liraglutide

Control group

Other group

Description:

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

Treatment:

Other: Control