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

Part of paid clinical trials in Glendale, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT01557166
Phase
PHASE3
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity
  • Obstructive Sleep Apnoea

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
  • placebo — DRUG
    Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise

Study Details

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.

Key Dates

Start date
Jun 7, 2012
Status verified
Sep 2017
Primary completion
Jun 1, 2013
Completion
Jun 17, 2013

Study Design

Enrollment
359 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide 3.0 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change From Baseline in Apnoea-hypopnoea Index (AHI) [ Time Frame: Week 0, Week 32 ]

Locations (37)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteGlendaleCalifornia91206-
Novo Nordisk Investigational SiteOceansideCalifornia92054-
Novo Nordisk Investigational SiteOrangeCalifornia92868-
Novo Nordisk Investigational SiteRedwood CityCalifornia94063-
Novo Nordisk Investigational SiteSan DiegoCalifornia92103-5801-
Novo Nordisk Investigational SiteSanta MonicaCalifornia90404-
Novo Nordisk Investigational SiteBrandonFlorida33511-
Novo Nordisk Investigational SiteHollywoodFlorida33024-
Novo Nordisk Investigational SiteMiamiFlorida33155-
Novo Nordisk Investigational SiteSouth MiamiFlorida33143-
Novo Nordisk Investigational SiteSt. PetersburgFlorida33707-
Novo Nordisk Investigational SiteTampaFlorida33603-
Novo Nordisk Investigational SiteWest Palm BeachFlorida33409-
Novo Nordisk Investigational SiteAtlantaGeorgia30342-
Novo Nordisk Investigational SiteMaconGeorgia31201-
Novo Nordisk Investigational SiteChicagoIllinois60634-
Novo Nordisk Investigational SiteVernon HillsIllinois60061-
Novo Nordisk Investigational SiteOverland ParkKansas66212-
Novo Nordisk Investigational SiteCrestview HillsKentucky41017-3464-
Novo Nordisk Investigational SiteLouisvilleKentucky40218-
Novo Nordisk Investigational SiteChevy ChaseMaryland20815-6905-
Novo Nordisk Investigational SiteNorth DartmouthMassachusetts02747-
Novo Nordisk Investigational SitePortageMichigan49024-4889-
Novo Nordisk Investigational SiteChesterfieldMissouri63017-
Novo Nordisk Investigational SiteNew YorkNew York10019-
Novo Nordisk Investigational SiteNew YorkNew York10065-
Novo Nordisk Investigational SiteWilmingtonNorth Carolina28401-
Novo Nordisk Investigational SiteDublinOhio43017-3521-
Novo Nordisk Investigational SitePhiladelphiaPennsylvania19104-3317-
Novo Nordisk Investigational SitePhiladelphiaPennsylvania19118-
Novo Nordisk Investigational SitePhiladelphiaPennsylvania19140-
Novo Nordisk Investigational SiteWarwickRhode Island02886-
Novo Nordisk Investigational SiteColumbiaSouth Carolina29201-2951-
Novo Nordisk Investigational SiteDallasTexas75231-
Novo Nordisk Investigational SiteDallasTexas75234-
Novo Nordisk Investigational SiteFort WorthTexas76135-
Novo Nordisk Investigational SiteViennaVirginia22182-

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