Trial results for the STARDUST study (NCT04881110) investigating liraglutide in people with type 2 diabetes and peripheral artery disease were posted on ClinicalTrials.gov on 2025-03-03. The study found that liraglutide significantly improved peripheral transcutaneous oxygen pressure, with a mean difference of 11.2 mmHg compared to the control group.
Background
Liraglutide is a medication often used in the management of type 2 diabetes. It has also been evaluated for its cardiovascular benefits. The STARDUST trial aimed to assess the effects of liraglutide on peripheral perfusion in individuals diagnosed with type 2 diabetes and peripheral artery disease, comparing it against aggressive treatment of cardio-metabolic risk factors.
Trial design
The STARDUST study (NCT04881110) was a Phase 4, open-label, two-arm randomized controlled trial that enrolled 60 participants. The trial investigated the effects of liraglutide in people with type 2 diabetes and peripheral artery disease. Participants were randomized to either receive liraglutide or aggressive treatment of cardio-metabolic risk factors. The primary outcome of the study was the change in peripheral transcutaneous oxygen tension.
Key results
The trial results indicated a significant improvement in peripheral transcutaneous oxygen pressure in the liraglutide group compared to the control group.
- For Peripheral Transcutaneous Oxygen Pressure, the Liraglutide Group had a mean of 54.2 mmHg (Standard Deviation: 5.9), while the Control Group had a mean of 43.4 mmHg (Standard Deviation: 4.8).
An analysis using a t-test (2-sided) for Peripheral Transcutaneous Oxygen Pressure showed a Mean Difference (Final Values) of 11.2 (95.0% CI: 8.0 to 14.5) with a p-value of 0.001.
Other measured outcomes included:
- For HbA1c Glucose Control, the Liraglutide Group had a mean of 6.7 percentage of HbA1c (Standard Deviation: 0.7), and the Control Group had a mean of 6.8 percentage of HbA1c (Standard Deviation: 0.8). A t-test showed a Mean Difference of -0.4 (95.0% CI: -0.8 to 0.01) with a p-value of 0.06.
- For Glucose Control, the Liraglutide Group had a median of 118.5 mg/dL, and the Control Group had a median of 117 mg/dL.
- For Weight Change, the Liraglutide Group had a mean of 78.5 Kg (Standard Deviation: 14.4), and the Control Group had a mean of 80.7 Kg (Standard Deviation: 12.5). A t-test showed a Mean Difference of -3.4 (95.0% CI: -14.3 to 7.4) with a p-value of 0.52.
- For BMI Change, the Liraglutide Group had a mean of 28.7 Kg/m2 (Standard Deviation: 4), and the Control Group had a mean of 27.7 Kg/m2 (Standard Deviation: 4.4). A t-test showed a Mean Difference of -1.1 (95.0% CI: -3.6 to 1.2) with a p-value of 0.33.
- For Waist Circumference Change, the Liraglutide Group had a mean of 108.9 cm (Standard Deviation: 10.3), and the Control Group had a mean of 104.1 cm (Standard Deviation: 11.6). A t-test showed a Mean Difference of -0.7 (95.0% CI: -1.7 to 0.1) with a p-value of 0.1.
Additionally, a Chi-squared analysis reported a Risk Ratio (RR) of 1.91 (95.0% CI: 1.26 to 2.9) with a p-value of 0.001.
What this means
The results of the STARDUST trial suggest that liraglutide may offer a significant benefit in improving peripheral perfusion in patients with type 2 diabetes and peripheral artery disease, as evidenced by the statistically significant increase in peripheral transcutaneous oxygen pressure. While other cardio-metabolic parameters like HbA1c, weight, BMI, and waist circumference did not show statistically significant differences between the groups in this study, the primary outcome indicates a potential role for liraglutide in addressing a key aspect of peripheral artery disease progression in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04881110, titled "Liraglutide and Peripheral Artery Disease," were posted on 2025-03-03 on clinicaltrials.gov.