Status:
COMPLETED
Liraglutide and Peripheral Artery Disease
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Type 2 Diabetes
Peripheral Arterial Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE4
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 ri...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04881110
Start Date
February 1 2021
End Date
December 31 2022
Last Update
March 3 2025
Active Locations (1)
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1
Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli
Napoli, Italy, 80138