Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial
An erratum to this article was published (JAMA Netw Open, 3 Nov 2025 ↗)
Primary result · Change in TcPo2Result — go to the resultEstimated treatment difference 11.2 mm Hg 95% CI 8.0–14.5Authors' conclusion
In this randomized clinical trial of people with type 2 diabetes and PAD, liraglutide increased peripheral perfusion detected by TcPo2 measurement during 6 months of treatment. These results support the use of liraglutide to prevent the clinical progression of PAD in individuals with type 2 diabetes.
Study context
- Population
- Individuals with T2D, peripheral artery disease (PAD) and TcPo2 between 30 and 49 mm Hg, University of Campania "Luigi Vanvitelli," Naples, Italy; mean age 67.5 years, 78% maleall analyzed
- Participants
- 55 individuals
- Comparison
- Liraglutide vs conventional treatment of cardiovascular risk factors
- Liraglutiden = 27
- Controln = 28reference
- Primary endpoint
- Coprimary: change from baseline of peripheral perfusion (TcPo2) between groups; proportion reaching 10% increase of TcPo2 from baseline
- Follow-up
- 6 months
Methodological detailsopen-label, single-centre, Conducted February 1, 2021 to June 30, 2022; final follow-up December 30, 2022
- Open-label
- Single-centre
- Conducted February 1, 2021 to June 30, 2022; final follow-up December 30, 2022
Primary result
Change in TcPo2
Estimated treatment difference
11.2 mm Hg
95% CI 8.0–14.5
P < 0.001
Liraglutidevs Control
estimated treatment difference 11.2 mm Hg (95% CI 8.0–14.5); P < 0.001
As reported in the abstract
Further findings
| Outcome | Liraglutide | Control | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| 10% increase of TcPo2 from baseline (coprimary) · 6 months | 89% | 46% | 1.91 (1.26–2.90) | P < 0.001 | |
| 0.20.5125Relative risk (log scale) |
| Outcome | Difference (mg/dL) (95% CI) | P value | |
|---|---|---|---|
| C-reactive protein | −0.4 (−0.7 to −0.07) | P = 0.02 | |
| −1−0.500.5Difference, mg/dL (linear scale) |
| Outcome | Difference (mg/g) (95% CI) | P value | |
|---|---|---|---|
| Urinary albumin to creatinine ratio | −119.4 (−195.0 to −43.8) | P = 0.003 | |
| −200−1000100Difference, mg/g (linear scale) |
| Outcome | Difference (m) (95% CI) | P value | |
|---|---|---|---|
| 6-minute walking distance | 25.1 (21.8–28.3) | P < 0.001 | |
| −2002040Difference, m (linear scale) |
Original publication
Liraglutide for Lower Limb Perfusion in People With Type 2 Diabetes and Peripheral Artery Disease: The STARDUST Randomized Clinical Trial. JAMA Netw Open. Published 4 March 2024. doi:10.
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