Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

The objective of this study is to evaluate the mechanism behind the anti-atherogenic effects of liraglutide.

Patients will be randomized 1:1 to an active treatment period of 26 weeks or placebo for 26 weeks.

It had two arms (groups): Liraglutide (other) and placebo (other).

The registry classes the interventions as drug.

More on the Plan

The primary endpoint is change from baseline to week 26 in vascular inflammation, assessed by Flour Deoxy Glucose (FDG)-Positron Emission Tomography/Computed Tomography (PET/CT).

FDG-PET/CT is currently the only clinically available technique for specific in vivo evaluation of vascular inflammation and for quantification of the effects of medical intervention on plaque inflammation.

FDG-PET of arteries has been proven very reproducible and therefore has high power to show a treatment effect in a smaller group of patients.

A number of complementary methods exist that assess different steps in the atherogenesis like endothelial function (e.g. endo-PAT, glycocalyx measurement), artery wall thickening (e.g. carotid intima media thickness), or coronary atherosclerosis (e.g. coronary artery calcium score).

Who Took Part

Enrollment: 102 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

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

Examples of who could join: Given written informed consent. Stable/no treatment of hypercholesterolemia 4 weeks before baseline PET/CT. Must be able to communicate with the investigator and understand informed consent.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: chronic pancreatitis / previous acute pancreatitis; known or suspected hypersensitivity to trial product(s) or related products; clinical signs of diabetic gastroparesis.

How the Study Was Run

Design: randomized, parallel-group and double-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.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-10-26 with completion listed for 2019-08-16.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change in vascular inflammation (time frame: baseline to week 26).

It also tracked 4 secondary outcomes, for example Change in Endothelial dysfunction, Change in Endothelial dysfunction, Coronary artery calcium score and Carotid intima media thickness.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 102 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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