Phase 4 N=60 Randomized Single-blind Treatment

Liraglutide and Peripheral Artery Disease

Type 2 Diabetes · Peripheral Arterial Disease

Bottom Line

View on ClinicalTrials.gov: NCT04881110 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Peripheral Transcutaneous Oxygen Pressure — 54.2; 43.4 mmHg — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Liraglutide (Drug); Control (Other)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: University of Campania Luigi Vanvitelli
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Peripheral Transcutaneous Oxygen Pressure	54.2; 43.4	<0.001 sig
SECONDARY HbA1c Glucose Control	6.7; 6.8	0.06
SECONDARY Glucose Control	118.5; 117	0.52
SECONDARY Weight Change	78.5; 80.7	0.33
SECONDARY BMI Change	28.7; 27.7	0.10
SECONDARY Waist Circumference Change	108.9; 104.1	0.81
SECONDARY Systolic Blood Pressure Change	130; 130	0.99
SECONDARY Lipid Profile	142.3; 158.8	0.72
SECONDARY C-reactive Protein (CRP) Change	0.5; 0.8	0.02 sig
SECONDARY Renal Function	1; 0.8	0.12
SECONDARY Estimated Glomerular Filtration Rate	71; 74.7	0.25
SECONDARY Angiogenesis	124; 68.4	<0.001 sig
SECONDARY Ankle-brachial Index (ABI) Change	0.9; 1	0.18
SECONDARY Sexual Hormonal Profile	45; 49.5	0.06
SECONDARY Male Sexual Function	12.4; 12.5	0.06
SECONDARY Female Sexual Function	20.4; 21.2	—
SECONDARY 6-minute Walking Test	364; 340	<0.001 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04881110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.