Effect of GLP-1 on Angiogenesis

What Was Tested

The trial (phase 4) is built around Liraglutide.

Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis.

It had two arms (groups): 1: Liraglutide (experimental) and 2: Add on oral antidiabetic medication (active comparator).

Metformin or sulfonylurea depending on monotherapy.

The registry classes the interventions as drug.

More on the Plan

T2D patients treated with GLP-1 analogs may suffer from microvascular complications such as macular oedema and proliferative retinopathy, characterized by excessive retinal angiogenesis.

The role of GLP-1 on endothelial cell (EC) growth, EC integrity and angiogenesis thus needs to be characterized.

Their aim is to provide the proof of concept that agonists of GLP-1 regulate angiogenesis in humans and identify the underlying mechanisms.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 diabetic patients (ADA criteria). Age \> 18 years. Obesity (BMI \>= 25 kg/m2). Treatment with Metformin and/or secretagogues.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: treatment with exenatide, liraglutide or other incretinergic regimen (\<1 month before recruitment); type 1 diabetes; acute disease or infection.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-05-18 with completion listed for 2017-08-08.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Difference of ANGPTL4 concentration at 4 weeks of treatment from baseline in Liraglutide and control group (time frame: At 1 month).

It also tracked 4 secondary outcomes, for example Difference of ANGPT2 concentration at 4 weeks of treatment from baseline in Liraglutide and control group and Difference of AngiomiR-126 expression at 4 weeks of treatment from baseline in Liraglutide and control group.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 50 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.