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



Status:Completed
Conditions:Insomnia Sleep Studies, Obesity Weight Loss, Pulmonary
Therapuetic Areas:Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 64
Updated:11/3/2017
Start Date:June 7, 2012
End Date:June 17, 2013

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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.


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
We found this trial at
34
sites
Santa Monica, California 90404
1181
mi
from
Santa Monica, CA
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Atlanta, Georgia 30318
801
mi
from
Atlanta, GA
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Brandon, Florida 33511
1125
mi
from
Brandon, FL
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2476 Argentia Road
Burlington, Ontario L5N 6M1
1026
mi
from
Burlington,
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Chesterfield, Missouri 63017
398
mi
from
Chesterfield, MO
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920 Massachusetts Avenue Northwest
Chevy Chase, Maryland 20815
1127
mi
from
Chevy Chase, MD
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Chicago, Illinois 60612
609
mi
from
Chicago, IL
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Columbia, South Carolina 29203
973
mi
from
Columbia, SC
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Crestview Hills, Kentucky 41017
721
mi
from
Crestview Hills, KY
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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806
mi
from
Dublin, OH
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Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Glendale, California 91206
1167
mi
from
Glendale, CA
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Hollywood, Florida 33024
1312
mi
from
Hollywood, FL
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Louisville, Kentucky 40213
659
mi
from
Louisville, KY
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Macon, Georgia 31201
867
mi
from
Macon, GA
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Miami, Florida 33136
1320
mi
from
Miami, FL
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New York, New York 10029
1290
mi
from
New York, NY
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North Dartmouth, Massachusetts 02747
1446
mi
from
North Dartmouth, MA
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Oceanside, California 92056
1142
mi
from
Oceanside, CA
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Orange, California 92868
1153
mi
from
Orange, CA
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Overland Park, Kansas 66209
190
mi
from
Overland Park, KS
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Philadelphia, Pennsylvania 19104
1223
mi
from
Philadelphia, PA
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Portage, Michigan 49024
716
mi
from
Portage, MI
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Redwood City, California 94062
1332
mi
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Redwood City, CA
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Saint Petersburg, Florida 33713
1115
mi
from
Saint Petersburg, FL
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San Diego, California 92111
1142
mi
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San Diego, CA
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South Miami, Florida 33143
1320
mi
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South Miami, FL
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Tampa, Florida 33612
1112
mi
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Tampa, FL
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Vernon Hills, Illinois 60061
605
mi
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Vernon Hills, IL
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920 Massachusetts Avenue Northwest
Vienna, Virginia 22182
1127
mi
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Vienna, VA
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Warwick, Rhode Island 02886
1423
mi
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Warwick, RI
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West Palm Beach, Florida 33409
1284
mi
from
West Palm Beach, FL
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Wilmington, North Carolina 28401
1135
mi
from
Wilmington, NC
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