Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea

What Was Tested

The trial (phase 3) is built around Liraglutide.

This trial is conducted in North America.

The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 359 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Body mass index equal to or above 30 kg/m\^2. Diagnosis of moderate or severe obstructive sleep apnoea (OSA). Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule and dietary advice and complete trial related questionnaires.

The full record lists 6 inclusion and 15 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 judgement of the investigator; respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2012-06-07 with completion listed for 2013-06-01.

It ran at 42 sites in United States (37) and Canada (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Apnoea-hypopnoea Index (AHI) (time frame: Week 0, Week 32).

It also tracked 3 secondary outcomes, for example Change From Baseline in Body Weight (kg), Change From Baseline in Fasting Plasma Glucose and Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 359 people.

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

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