The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)

What Was Tested

This registered phase 4 trial tested Liraglutide.

Lipoprotein (a) \[Lp (a)\] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2).

Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R).

It had two arms (groups): Group A (experimental) and Group B (active comparator).

Type 2 diabetic patients whom were prescribed GLP-1R agonists by the endocrinologist, according to usual clinical practice (liraglutide, exenatide, lixisenatide). The intervention is the prescription of an GLP-1R agonist (liraglutide, exenatide, lixisenatide).

Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice.

The registry classes the interventions as drug.

More on the Plan

Background: Lipoprotein (a) \[Lp (a)\] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2).

Hypothesis: Treatment with GLP-1R agonists will lower the levels of Lp (a) in patients with DM-2.

Objective: The objective of the study is to confirm in humans the results observed in vitro.

The patients will be distributed in two groups according to the treatment prescribed by the endocrinologist during the visit of routine monitoring: group A (20 patients who were prescribred treatment with GLP-1R agonists) and group B (20 patients who were not prescribed this treatment).

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 50 years up to 65 years.

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

Examples of who could join: Type 2 diabetes. Age between 50-65 years. Written informed consent.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: active glp-1r agonist, insulin or dpp-iv treatment; liver failure (3lsn ast and/or alt).

How the Study Was Run

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

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.

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 2014-10 with completion listed for 2015-07.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in blood levels of Lipoprotein (a) (Lp(a)) (time frame: Baseline and two months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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