Liraglutide and Peripheral Artery Disease

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campania "Luigi Vanvitelli"
• Treatments: Liraglutide

Criteria

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