Liraglutide and Heart Failure in Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Liraglutide.

Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin with insulinotropic properties.

Apart from the glycemic actions, cardiovascular effects by GLP-1 have recently been reviewed.

It had two arms (groups): liraglutide (experimental) and glimepiride (active comparator).

The registry classes the interventions as drug.

More on the Plan

The subjects will attend a screening visit (Visit 1) in order to assess their eligibility.

At Visit 2, subjects will be supplied with a glucose meter (Abbot Contour) and instruction on use of the device including regular calibration according to the manufacturer's instruction.

Subjects will be instructed on how to record the results of the self measured plasma glucose (SMPG) values in the meter.

Subjects will then ask to monitor a 7 point profile glucose curve consecutively in three days before visit 3, at visit 4 and at the end of treatment (visit 5).

Who Took Part

Enrollment: 62 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetes. Heart Failure, visualized with echocardiography, one of the following (2.1, 2.2 or 2.3). If antihypertensive treatment, the medication has to be stable, no change, for the last 1 month. Male and female subjects, 18-80 years of age. Signed informed consent form.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: type 1 diabetes (autoantibody positive); any history of receiving glp-1 analogues or dipeptidyl peptidase inhibitors (dpp-iv inhibitor) or glimeperide; previous treatment with glitazones within 6 months.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2012-01 with completion listed for 2016-08.

It ran at 2 sites in Sweden (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Left ventricle longitudinal function and/or functional reserve during rest and/or after exercise using tissue Doppler echocardiography (time frame: 18 weeks).

It also tracked 13 secondary outcomes, for example 24-hour blood pressure, Energy delivering from the carotid artery, Gene and protein expression (Affymetrix/proteomics), Plasma markers of inflammation i.e. hsCRP, IL-6, TNF-α and PAI-1, Plasma markers of endothelial activation i.e. E-selectin, VCAM-1, ICAM-1 and plasma levels of nitrate/nitrite and Lipids.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 62 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.