Liraglutide and Peripheral Artery Disease

What Was Tested

This registered phase 4 trial tested Liraglutide.

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 primary outcome of the study is the change of peripheral transcutaneous oxygen tension between groups at three and six months.

It had two arms (groups): Liraglutide group (experimental) and Control group (other).

Patients in this arm will receive liraglutide, according to the current clinical practice.

Patients in this arm will be strictly monitored with optimization of the therapy for atherosclerosis major risk factors.

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 35 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Treatment of diabetes with metformin, insulin and/or sulfonylurea.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Liraglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-02-01 with completion listed for 2022-12-31.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Peripheral Transcutaneous Oxygen Pressure (time frame: 6 months).

It also tracked 16 secondary outcomes, for example HbA1c Glucose Control, Glucose Control, Weight Change, BMI Change, Waist Circumference Change and Systolic Blood Pressure Change.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 60 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.