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

September 29, 2017 updated by: Novo Nordisk A/S

Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

359

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7R 1E2
        • Novo Nordisk Investigational Site
      • Hamilton, Ontario, Canada, L8L 5G8
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M4P 1P2
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5M 1C7
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5M1C7
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Glendale, California, United States, 91206
        • Novo Nordisk Investigational Site
      • Oceanside, California, United States, 92054
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92868
        • Novo Nordisk Investigational Site
      • Redwood City, California, United States, 94063
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92103-5801
        • Novo Nordisk Investigational Site
      • Santa Monica, California, United States, 90404
        • Novo Nordisk Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33155
        • Novo Nordisk Investigational Site
      • Saint Petersburg, Florida, United States, 33707
        • Novo Nordisk Investigational Site
      • South Miami, Florida, United States, 33143
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Novo Nordisk Investigational Site
      • Macon, Georgia, United States, 31201
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Novo Nordisk Investigational Site
      • Vernon Hills, Illinois, United States, 60061
        • Novo Nordisk Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017-3464
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40218
        • Novo Nordisk Investigational Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815-6905
        • Novo Nordisk Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Novo Nordisk Investigational Site
    • Michigan
      • Portage, Michigan, United States, 49024-4889
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, United States, 10065
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10019
        • Novo Nordisk Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
    • Ohio
      • Dublin, Ohio, United States, 43017-3521
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104-3317
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19118
        • Novo Nordisk Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Novo Nordisk Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201-2951
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75234
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76135
        • Novo Nordisk Investigational Site
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Body mass index equal to or above 30 kg/m^2
  • Stable body weight (less than 5% self-reported change during the previous 3 months)
  • Diagnosis of moderate or severe obstructive sleep apnoea (OSA)
  • Unwilling or unable to use continuous positive airway pressure (CPAP) (or other positive airway pressure) treatment. No CPAP (or other positive airway pressure) treatment for at least four weeks prior to screening
  • 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

Exclusion Criteria:

  • 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
  • Glycosylated haemoglobin (HbA1c) equal to or above 6.5%
  • Significant craniofacial abnormalities that may cause OSA
  • Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
  • Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone within the previous 3 months prior to screening
  • Obesity induced by drug treatment
  • Treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine within the last 3 month prior to screening
  • Previous surgical treatment for obesity
  • Screening calcitonin equal to or above 50 ng/L
  • Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
  • Personal history of non-familial Medullary Thyroid Carcinoma
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • History of Major Depressive Disorder or suicide attempts
  • Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
Experimental: Liraglutide 3.0 mg
Drug: liraglutide
3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Apnoea-hypopnoea Index (AHI)
Time Frame: Week 0, Week 32
Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0-14.9; moderate 15.0-29.9; severe ≥30.0 events/hour.
Week 0, Week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight (kg)
Time Frame: Week 0, week 32
Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.
Week 0, week 32
Change From Baseline in Fasting Plasma Glucose
Time Frame: Week 0, week 32
Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.
Week 0, week 32
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Time Frame: Week 0, week 32
Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.
Week 0, week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 17, 2013

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8022-3970
  • U1111-1126-6260 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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