Status
Completed
Phase
Phase 4
Enrollment
60
Locations
1
Results
Posted
Publications
2
Study 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.
An 18-month extension of the follow-up will be performed for all the study population, according to guidelines and good clinical practice. The follow-up will include the glyco-metabolic parameters and the main cardiovascular risk factors, including TcPO2 assessment. Data from this extended observation will be collected for additional analyses (mostly regarding the durability of the effects). Individuals who will be lost during follow-up and/or discontinue or modify the glucose-lowering treatment will be excluded from the analyses.
Interventions
DRUG
Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
OTHER
Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
Timeline
First posted
May 11, 2021
Study start
Feb 1, 2021
Primary completion
Dec 31, 2022
Study completion
Dec 31, 2022
Results posted
Mar 3, 2025
Registry updated
Mar 3, 2025
Outcomes
Peripheral Transcutaneous Oxygen Pressure
Time frame · 6 months
Transcutaneous oxygen pressure (mmHg) on the lowest value recorded on anterior or posterior tibial artery after 6 months
HbA1c Glucose Control
Time frame · 6 months
HbA1c values after 6 months
Glucose Control
Time frame · 6 months
fasting glucose differences between groups
Weight Change
Time frame · 6 months
Weight value at 6 months minus value at baseline
BMI Change
Time frame · 6 months
BMI value at 6 months minus value at baseline
Waist Circumference Change
Time frame · 6 months
Waist circumference value at 6 months minus value at baseline
Systolic Blood Pressure Change
Time frame · 6 months
systolic blood pressure value at 6 months minus value at baseline
Lipid Profile
Time frame · 6 months
total cholesterol after 6 months
C-reactive Protein (CRP) Change
Time frame · 6 months
CRP value at 6 months minus value at baseline
Renal Function
Time frame · 6 months
creatinine levels after 6 months
Estimated Glomerular Filtration Rate
Time frame · 6 months
estimated glomerular filtration rate after 6 months
Eligibility
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
Study locations
Italy. Showing up to 24 locations stored in the fast local snapshot.
Unit of Endocrinology and Metabolic Diseases and Unit of Diabetes, University of Campania Luigi Vanvitelli
Naples, Italy
Publications
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