Liraglutide and Peripheral Artery Disease
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.
Timeline
- Start
- 2021-02-01
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liraglutide | Peptide | 1.8 mg | Subcutaneous |