Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
NCT ID: NCT01557166
Last Updated: 2017-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
359 participants
INTERVENTIONAL
2012-06-07
2013-06-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Liraglutide 3.0 mg
liraglutide
3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
Placebo
placebo
Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
Interventions
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liraglutide
3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
placebo
Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Glendale, California, United States
Novo Nordisk Investigational Site
Oceanside, California, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
Redwood City, California, United States
Novo Nordisk Investigational Site
San Diego, California, United States
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Santa Monica, California, United States
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Brandon, Florida, United States
Novo Nordisk Investigational Site
Hollywood, Florida, United States
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Miami, Florida, United States
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South Miami, Florida, United States
Novo Nordisk Investigational Site
St. Petersburg, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Macon, Georgia, United States
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Chicago, Illinois, United States
Novo Nordisk Investigational Site
Vernon Hills, Illinois, United States
Novo Nordisk Investigational Site
Overland Park, Kansas, United States
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States
Novo Nordisk Investigational Site
Louisville, Kentucky, United States
Novo Nordisk Investigational Site
Chevy Chase, Maryland, United States
Novo Nordisk Investigational Site
North Dartmouth, Massachusetts, United States
Novo Nordisk Investigational Site
Portage, Michigan, United States
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States
Novo Nordisk Investigational Site
Dublin, Ohio, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Warwick, Rhode Island, United States
Novo Nordisk Investigational Site
Columbia, South Carolina, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
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Fort Worth, Texas, United States
Novo Nordisk Investigational Site
Vienna, Virginia, United States
Novo Nordisk Investigational Site
Burlington, Ontario, Canada
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Novo Nordisk Investigational Site
Toronto, Ontario, Canada
Countries
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References
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O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.
Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.
Blackman A, Foster GD, Zammit G, Rosenberg R, Aronne L, Wadden T, Claudius B, Jensen CB, Mignot E. Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial. Int J Obes (Lond). 2016 Aug;40(8):1310-9. doi: 10.1038/ijo.2016.52. Epub 2016 Mar 23.
Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1126-6260
Identifier Type: OTHER
Identifier Source: secondary_id
NN8022-3970
Identifier Type: -
Identifier Source: org_study_id