Incretin and Treatment With Inhibition of Sodium-glucose Cotransporter-2 Combination Insights Into Mechanisms Implicated in Congestive Heart Failure: "NATRIURETIC" Trial

What Was Tested

This registered phase 2 trial tested Liraglutide.

This study aims to provide essential mechanistic insights into natriuretic and hemodynamic effects of SGLT2i and GLP-1RA agents in T2D patients.

Ultimately, by obtaining physiological data in T2D patients without HF, their aims are to gain insight into how the use of this combined therapy may be used in T2D with HF in future work.

It had two arms (groups): Liraglutide (experimental) and Empagliflozin (experimental).

The registry classes the interventions as drug.

More on the Plan

Liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), is a subcutaneous drug, used for treating T2D patients.

Furthermore, liraglutide attenuated the risk of progressive albuminuria as well.

T2D patients are at high risk for development of both HF and atherosclerotic diseases.

Who Took Part

36 planned participants were the target.

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: Men and women diagnosed with T2D ≥6 months prior to informed consent;. Age \>18 years;. Body Mass Index (BMI) 18.5-40.0 kg/m2;. Blood pressure ≤160/100 mmHg at screening, \>90/60 mmHg;.

The full record lists 8 inclusion and 23 exclusion criteria; among the exclusions: type 1 diabetes;; leukocyte and/or nitrite positive urinalysis that is untreated;; severe hypoglycaemia within 2 months prior to screening;.

How the Study Was Run

The set-up was randomized, sequential and open-label.

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

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

It started in 2019-01-24 with completion listed for 2023-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proximal tubular natriuresis (time frame: up to 12 weeks).

It also tracked 7 secondary outcomes, for example Glomerular Filtration Rate, Systolic blood pressure, Body weight, Arterial stiffness, Systemic vascular resistance and Urinary concentration of the renin-angiotensin aldosterone system (RAAS) markers.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 36 people.

Its size is small, so on its own it can only give an early look.

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.