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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01557166
First received: March 15, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Metabolism and Nutrition Disorder
Obesity
Obstructive Sleep Apnoea
Drug: liraglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change from baseline in apnoea-hypopnoea index (AHI) [ Time Frame: Week 0, week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in body weight (kg) [ Time Frame: Week 0, week 32 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: Week 0, week 32 ] [ Designated as safety issue: No ]
  • Change from baseline in glycosylated haemoglobin (HbA1c) (%) [ Time Frame: Week 0, week 32 ] [ Designated as safety issue: No ]

Enrollment: 359
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide 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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557166

  Show 37 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Anja Frederiksen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01557166     History of Changes
Other Study ID Numbers: NN8022-3970, U1111-1126-6260
Study First Received: March 15, 2012
Last Updated: June 10, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Novo Nordisk A/S:
OSA

Additional relevant MeSH terms:
Apnea
Malnutrition
Nutrition Disorders
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Glucagon-Like Peptide 1
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014