A Pilot Study of the Effects on Sleep Disordered Breathing (SDB) When Using the Drug Liraglutide for 4 Weeks

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Liraglutide for sleep apnea (obstructive).

This is an open label, controlled study.

This study is testing liraglutide in 20 adults without diabetes that are diagnosed with sleep apnea.The treatment group will be compared to a control group of 10 adults without diabetes who have sleep apnea but will not use liraglutide.

It had two arms (groups): Treatment group- liraglutide (experimental) and Control group (no intervention).

Control group.

The registry classes the interventions as drug.

More on the Plan

This is a pilot study aimed at measuring the change in obstructive apnea/hypopnea index in non-diabetic patients being treated for the first time with the glucagon-like peptide-1 (GLP-1) agonist, Liraglutide.

Sleep disordered breathing (SDB) consists of nocturnal alveolar hypoventilation and / or obstructive sleep apnea which result from abnormalities in upper airway tone and ventilation during sleep.

This is an open label, non-randomized, controlled pilot study.

Subjects are heavy to obese non-diabetic adults that are diagnosed with sleep apnea. 20 subjects will be treated with liraglutide for 4 weeks and compared to 10 untreated controls.

Who Took Part

Enrollment: 34 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age 18-60 years. Diagnosis of severe obstructive sleep apnea (OSA) AHI ≥ 8 /hour of sleep. Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule. BMI of ≥ 27. For Cohort 1: If female of childbearing capacity, willing to use acceptable birth control during use of study drug.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: treatment with glucagon-like peptide-1 (glp-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening; diagnosis of type 1 or type 2 diabetes per judgment of the investigator; BMI \< 27.

How the Study Was Run

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-04 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Apnea Hypopnea Index (AHI) From Baseline (time frame: Baseline and 4 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Liraglutide in 34 people with sleep apnea (obstructive).

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, Sleep apnea (obstructive) research.