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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
359
3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
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.
Time frame: Week 0, Week 32
Change From Baseline in Body Weight (kg)
Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.
Time frame: Week 0, week 32
Change From Baseline in Fasting Plasma Glucose
Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.
Time frame: Week 0, week 32
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.
Time frame: Week 0, week 32
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Novo Nordisk Investigational Site
Glendale, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Redwood City, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Brandon, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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South Miami, Florida, United States
...and 32 more locations