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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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