Liraglutide Actions on the Liver: Effects on Glucose Phosphorylation

What Was Tested

This registered phase 4 trial tested Liraglutide.

Type 2 diabetes is a chronic disease that has reached epidemic proportions.

It had 1 arm (groups): single arm (other).

The registry classes the interventions as drug.

More on the Plan

It is known that liraglutide impacts favorably glucose homeostasis in type 2 diabetic patients, but not the exact mechanism of this effect.

In particular, liraglutide's acute and chronic effects on the liver are not well understood.

The aim of their study is to determine whether liraglutide acutely and/or chronically changes hepatic GCK activity in vivo in type 2 diabetic patients, and to quantify this effect.

GCK activity (acute effect) during IVGTTs with and without liraglutide administration.

Who Took Part

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 18- 65 years of age (inclusive). Ability to provide informed consent before any trial-related activities. Ability to return for follow up visit. Adequate IV access. If a female of childbearing potential, non-pregnant and taking reliable contraception.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures; liver disease; history of alcoholism; known or suspected allergy to liraglutide.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-12 with completion listed for 2020-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Liver glucokinase activity (acute effect) (time frame: 12 months). Liver glucokinase activity (chronic effect) (time frame: 12 months).

It also tracked 2 secondary outcomes, for example insulin sensitivity and Acute insulin response to glucose and the disposition index.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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