Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
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|ClinicalTrials.gov Identifier: NCT01557166|
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : February 9, 2015
Last Update Posted : November 1, 2017
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Experimental: Liraglutide 3.0 mg||
3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
|Placebo Comparator: Placebo||
Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557166
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|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|