Primary outcome
What STARDUST measured first
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 54.2(5.9) | 43.4(4.8) |
Phase 4 · Liraglutide
STARDUST trial results
Effects of the Glucagon Like-peptide 1 (GLP-1) Receptor Agonist Liraglutide on Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: a Randomized Controlled Trial
Peripheral Transcutaneous Oxygen Pressure (mmHg), 6 months. Liraglutide Group: 54.2; Control Group: 43.4.
- Participants
- 60
- Status
- completed
- Completed
- 2022-12-31
- Sponsor
- University of Campania Luigi Vanvitelli
As posted on ClinicalTrials.gov (NCT04881110), updated at source Mar 3, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Secondary outcomes
What else it measured
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 6.7(0.7) | 6.8(0.8) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 118.5(91 to 132.5) | 117(98 to 122) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 78.5(14.4) | 80.7(12.5) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 28.7(4) | 27.7(4.4) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 108.9(10.3) | 104.1(11.6) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 130(120 to 130) | 130(125 to 140) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 142.3(40.6) | 158.8(55.1) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 0.5(0.5) | 0.8(0.5) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 1(0.8 to 1.2) | 0.8(0.8 to 1) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 71(18.4) | 74.7(13.4) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 124(77.5 to 188) | 68.4(52.2 to 80.8) |
| Liraglutide Groupn=27 | Control Groupn=28 |
|---|---|
| 0.9(0.9 to 1) | 1(0.9 to 1.1) |
The trial
How STARDUST was run
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.
- Liraglutide group: Patients in this arm will receive liraglutide, according to the current clinical practice.
- Control group: Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.
Who could join the trial
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
Published papers
Papers from STARDUST
- 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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.