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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
359

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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