Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients

What Was Tested

The trial (phase 4) is built around Liraglutide for fatty liver & elevated liver enzymes.

The most important cause of mortality amongst DM2 patients is cardiovascular disease.

An early finding of cardiovascular disease in DM2 and obesity is diastolic dysfunction.

It had two arms (groups): Liraglutide (active comparator) and Liraglutide-placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Especially cardiovascular disease contributes for a great deal to the high mortality rates.

Unfortunately, despite lifestyle advises, glucose lowering therapy and co-treatment of other risk factors such as hypertension and dyslipidemia, complication rates remain high.

A hopeful new therapeutic agent is the Glucagon Like Peptide -1 analogue Liraglutide.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years up to 69 years.

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

Examples of who could join: Age \> 18 years and \< 70 years. BMI \> 25 kg/m2. Normal sitting blood pressure \< 150/85 mm Hg and stable for at least one month.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: use of thiazolidinediones (tzd), glp-1 analogues, dpp-iv inhibitors, fibrates, prednisone, cytostatic or antiretroviral therapy within 6 months prior to the study; hereditary lipoprotein disease; psychiatric disorders and / or use of antipsychotic or antidepressant drugs at present or in the past.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-11 with completion listed for 2016-03.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Stroke volume (time frame: 0 and 26 weeks). Ejection Fraction (time frame: 0 and 26 weeks). Cardiac output (time frame: 0 and 26 weeks).

It also tracked 14 secondary outcomes, for example Aorta and carotid vessel wall imaging, Aorta and carotid vessel wall imaging, Aorta and carotid vessel wall imaging, Aorta and carotid vessel wall imaging, Aorta and carotid vessel wall imaging and Adipose tissue distribution.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 50 people with fatty liver & elevated liver enzymes.

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

More context: the Liraglutide compound page, Fatty liver & elevated liver enzymes research.