Liraglutide and Peripheral Artery Disease (NCT04881110) | Clinical Trial Compass
CompletedPhase 4
Liraglutide and Peripheral Artery Disease
Italy60 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested liraglutide — a GLP-1 medication I may have heard of — in people with both Type 2 diabetes and peripheral artery disease, measuring oxygen levels in the tissues of the legs; given that it's now completed, has the full data been published, and what did it show about whether liraglutide actually improved blood flow or tissue oxygen in people like me?
2Since peripheral transcutaneous oxygen pressure was the main thing being measured, what does that number actually tell us about the health of my legs and feet, and is it something my care team already tracks for my condition?
3This was a Phase 4 trial, meaning liraglutide was already approved when it was studied here — does that mean there's a stronger safety record for this drug compared to earlier-phase trials, and are there any risks specific to using it in people who also have peripheral artery disease?
4If the results of this trial look promising, would liraglutide be something worth considering in my own treatment plan for managing both my diabetes and my circulation problems, or is there a standard treatment path I should try first?
5Peripheral artery disease can affect people very differently depending on how advanced it is — do you know whether this trial enrolled patients at a similar stage to where I am now, and does that affect whether its findings would even be relevant to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.