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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557166
• Other study ID #: NN8022-3970
• Secondary ID: U1111-1126-6260
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2012
• Last updated: September 29, 2017
• Start date: June 7, 2012
• Est. completion date: June 17, 2013

Study information

• Verified date: September 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: June 17, 2013
• Est. primary completion date: June 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	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
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Brandon	Florida
United States	Novo Nordisk Investigational Site	Chesterfield	Missouri
United States	Novo Nordisk Investigational Site	Chevy Chase	Maryland
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Columbia	South Carolina
United States	Novo Nordisk Investigational Site	Crestview Hills	Kentucky
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dublin	Ohio
United States	Novo Nordisk Investigational Site	Fort Worth	Texas
United States	Novo Nordisk Investigational Site	Glendale	California
United States	Novo Nordisk Investigational Site	Hollywood	Florida
United States	Novo Nordisk Investigational Site	Louisville	Kentucky
United States	Novo Nordisk Investigational Site	Macon	Georgia
United States	Novo Nordisk Investigational Site	Miami	Florida
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	North Dartmouth	Massachusetts
United States	Novo Nordisk Investigational Site	Oceanside	California
United States	Novo Nordisk Investigational Site	Orange	California
United States	Novo Nordisk Investigational Site	Overland Park	Kansas
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	Portage	Michigan
United States	Novo Nordisk Investigational Site	Redwood City	California
United States	Novo Nordisk Investigational Site	Saint Petersburg	Florida
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	Santa Monica	California
United States	Novo Nordisk Investigational Site	South Miami	Florida
United States	Novo Nordisk Investigational Site	Tampa	Florida
United States	Novo Nordisk Investigational Site	Vernon Hills	Illinois
United States	Novo Nordisk Investigational Site	Vienna	Virginia
United States	Novo Nordisk Investigational Site	Warwick	Rhode Island
United States	Novo Nordisk Investigational Site	West Palm Beach	Florida
United States	Novo Nordisk Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

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 — View Citation

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. In — View Citation

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 — View Citation

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 — View Citation

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 A — View Citation

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 Po — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Apnoea-hypopnoea Index (AHI)	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	Change From Baseline in Body Weight (kg)	Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.	Week 0, week 32
Secondary	Change From Baseline in Fasting Plasma Glucose	Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.	Week 0, week 32
Secondary	Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)	Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.	Week 0, week 32

External Links

•   Clinical Trials at Novo Nordisk