Effect of Liraglutide on Diastolic Dysfunction on Cardiac MRI in Type 2 Diabetes Patients

What Was Tested

The trial (phase 4) is built around Liraglutide.

Secondary if the treatment has any effect on the perfusion of the heart on a cardiac-MRI.

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

The registry classes the interventions as drug.

More on the Plan

Furthermore, analyzing cardiac MRI indices of fibrosis and the effect on myocardial perfusion.

The investigators find that especially diastolic dysfunction is of interest, because it is highly overrepresented in DM2 patients and no treatment exists.

No previous study has tested the effect of treatment with a glucagon-like peptide 1 analogue on diastolic dysfunction.

Design: A randomised double-blinded placebo-controlled clinical trial.

Who Took Part

The registry lists 40 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: Male or female patient fully capable of informed consent. Age 18-80 years (both years inclusive). T2DM diagnosed at least 3 months prior to visit 0. NYHA class I-III at visit 0. E/e\* ≥ 9 or e\* (lateral) ≤10 cm/sec, or both.

The full record lists 11 inclusion and 36 exclusion criteria; among the exclusions: lack of consent; NYHA class IV; type 1 diabetes mellitus.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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.

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 and investigator.

It started in 2016-02 with completion listed for 2019-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in diastolic properties as assessed by CMR (time frame: Measured in week 18 and compared to baseline). Change in diastolic properties as assessed by CMR (time frame: Measured in week 18 and compared to baseline).

It also tracked 2 secondary outcomes, for example MRI indices of myocardial perfusion and Echocardiographic indices of diastolic dysfunction.

What This Means in Plain Language

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