Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
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| ClinicalTrials.gov Identifier: NCT01557166 |
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Recruitment Status :
Completed
First Posted : March 19, 2012
Results First Posted : February 9, 2015
Last Update Posted : November 1, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
- Study Details
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolism and Nutrition Disorder Obesity Obstructive Sleep Apnoea | Drug: liraglutide Drug: placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 359 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | June 7, 2012 |
| Actual Primary Completion Date : | June 1, 2013 |
| Actual Study Completion Date : | June 17, 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Obstructive sleep apnea
MedlinePlus related topics:
Sleep Apnea
Drug Information available for:
Liraglutide
| Arm | Intervention/treatment |
|---|---|
| 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 |
| Placebo Comparator: Placebo |
Drug: placebo
Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557166
Locations
| United States, California | |
| Novo Nordisk Investigational Site | |
| 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 | |
| United States, Florida | |
| Novo Nordisk Investigational Site | |
| 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 | |
| United States, Georgia | |
| Novo Nordisk Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| Novo Nordisk Investigational Site | |
| Macon, Georgia, United States, 31201 | |
| United States, Illinois | |
| Novo Nordisk Investigational Site | |
| Chicago, Illinois, United States, 60634 | |
| Novo Nordisk Investigational Site | |
| Vernon Hills, Illinois, United States, 60061 | |
| United States, Kansas | |
| Novo Nordisk Investigational Site | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Kentucky | |
| Novo Nordisk Investigational Site | |
| Crestview Hills, Kentucky, United States, 41017-3464 | |
| Novo Nordisk Investigational Site | |
| Louisville, Kentucky, United States, 40218 | |
| United States, Maryland | |
| Novo Nordisk Investigational Site | |
| Chevy Chase, Maryland, United States, 20815-6905 | |
| United States, Massachusetts | |
| Novo Nordisk Investigational Site | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| United States, Michigan | |
| Novo Nordisk Investigational Site | |
| Portage, Michigan, United States, 49024-4889 | |
| United States, Missouri | |
| Novo Nordisk Investigational Site | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, New York | |
| Novo Nordisk Investigational Site | |
| New York, New York, United States, 10019 | |
| Novo Nordisk Investigational Site | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Novo Nordisk Investigational Site | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| Novo Nordisk Investigational Site | |
| Dublin, Ohio, United States, 43017-3521 | |
| United States, Pennsylvania | |
| Novo Nordisk Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104-3317 | |
| Novo Nordisk Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19118 | |
| Novo Nordisk Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Rhode Island | |
| Novo Nordisk Investigational Site | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| Novo Nordisk Investigational Site | |
| Columbia, South Carolina, United States, 29201-2951 | |
| United States, Texas | |
| Novo Nordisk Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| Novo Nordisk Investigational Site | |
| Dallas, Texas, United States, 75234 | |
| Novo Nordisk Investigational Site | |
| Fort Worth, Texas, United States, 76135 | |
| United States, Virginia | |
| Novo Nordisk Investigational Site | |
| Vienna, Virginia, United States, 22182 | |
| Canada, Ontario | |
| Novo Nordisk Investigational Site | |
| 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 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01557166 |
| Other Study ID Numbers: |
NN8022-3970 U1111-1126-6260 ( Other Identifier: WHO ) |
| First Posted: | March 19, 2012 Key Record Dates |
| Results First Posted: | February 9, 2015 |
| Last Update Posted: | November 1, 2017 |
| Last Verified: | September 2017 |
Keywords provided by Novo Nordisk A/S:
|
OSA |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Nutrition Disorders Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Liraglutide Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |