Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients?

What Was Tested

This registered phase 2 trial tested Liraglutide.

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

The registry classes the interventions as drug.

More on the Plan

The power calculation was based on the primary outcome measurement: Change in glucose tolerance.

The glucose tolerance was estimated by the total Area Under the Curve (AUC) following a 4-hour 75-g.

Oral Glucose Tolerance Test (OGTT).

The expected mean total AUC for the plasma glucose excursion following a 4-hour 75-g.

Who Took Part

Enrollment: 103 actual participants 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: Informed oral and written consent. Stable co-medications for at least 30 days. Age ≥18 years and ≤65 years. BMI ≥27 kg/m2.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: compulsory treatment; females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures; subjects treated with corticosteroids or other hormone therapy (except estrogens).

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

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

It started in 2013-04 with completion listed for 2016-03.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glucose tolerance (time frame: Baseline - 16 weeks).

It also tracked 8 secondary outcomes, for example Dysglycaemia, Body weight, Secretion of incretin hormons, insulin sensitivity and beta cell function, Body composition, Lipid profile and liver function and Psychopathology.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 103 people.

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.