Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT01885208
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
  • exenatide — DRUG
    One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly

Study Details

This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

Key Dates

Start date
Dec 2, 2013
Status verified
May 2019
Primary completion
Jul 13, 2015
Completion
Jul 13, 2015

Study Design

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

Arms

  • Experimental: Semaglutide 1.0 mg
  • Active Comparator: Exenatide ER 2.0 mg

Primary Outcome Measure

Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 56 ]

Locations (76)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteAnnistonAlabama36207-
Novo Nordisk Investigational SiteBirminghamAlabama35216-
Novo Nordisk Investigational SitePell CityAlabama35128-
Novo Nordisk Investigational SiteGlendaleArizona85306-4652-
Novo Nordisk Investigational SiteMesaArizona85213-
Novo Nordisk Investigational SitePhoenixArizona85027-
Novo Nordisk Investigational SiteBurbankCalifornia91505-
Novo Nordisk Investigational SiteHawaiian GardensCalifornia90716-
Novo Nordisk Investigational SiteLomitaCalifornia90717-
Novo Nordisk Investigational SiteLos AngelesCalifornia90017-
Novo Nordisk Investigational SiteLos AngelesCalifornia90022-
Novo Nordisk Investigational SiteLos AngelesCalifornia90057-
Novo Nordisk Investigational SiteNorthridgeCalifornia91324-
Novo Nordisk Investigational SiteNorthridgeCalifornia91325-
Novo Nordisk Investigational SiteSan DiegoCalifornia92108-
Novo Nordisk Investigational SiteTustinCalifornia92780-
Novo Nordisk Investigational SiteColorado SpringsColorado80906-
Novo Nordisk Investigational SiteColorado SpringsColorado80909-
Novo Nordisk Investigational SiteBradentonFlorida34201-
Novo Nordisk Investigational SiteBrandonFlorida33511-
Novo Nordisk Investigational SiteCoral GablesFlorida33134-
Novo Nordisk Investigational SiteHialeahFlorida33012-
Novo Nordisk Investigational SiteJacksonvilleFlorida32207-
Novo Nordisk Investigational SiteMiamiFlorida33144-
Novo Nordisk Investigational SiteMiamiFlorida33145-
Novo Nordisk Investigational SiteMiamiFlorida33174-
Novo Nordisk Investigational SiteMiami LakesFlorida33016-
Novo Nordisk Investigational SitePlantationFlorida33324-
Novo Nordisk Investigational SiteSavannahGeorgia31406-
Novo Nordisk Investigational SiteChicagoIllinois60634-
Novo Nordisk Investigational SiteFranklinIndiana46131-
Novo Nordisk Investigational SiteGreenfieldIndiana46140-
Novo Nordisk Investigational SiteMuncieIndiana47304-
Novo Nordisk Investigational SiteLouisvilleKentucky40213-
Novo Nordisk Investigational SiteMadisonvilleKentucky42431-
Novo Nordisk Investigational SiteHyattsvilleMaryland20782-
Novo Nordisk Investigational SiteKalamazooMichigan49009-
Novo Nordisk Investigational SiteSt LouisMissouri63141-
Novo Nordisk Investigational SiteLas VegasNevada89103-
Novo Nordisk Investigational SiteMine HillNew Jersey07803-
Novo Nordisk Investigational SiteAlbuquerqueNew Mexico87102-
Novo Nordisk Investigational SiteNorth MassapequaNew York11758-1802-
Novo Nordisk Investigational SiteSyracuseNew York13210-
Novo Nordisk Investigational SiteWest SenecaNew York14224-
Novo Nordisk Investigational SiteGreensboroNorth Carolina27408-
Novo Nordisk Investigational SiteHickoryNorth Carolina28601-
Novo Nordisk Investigational SiteWhitevilleNorth Carolina28472-
Novo Nordisk Investigational SiteAkronOhio44311-
Novo Nordisk Investigational SiteCincinnatiOhio45255-
Novo Nordisk Investigational SiteClevelandOhio44122-
Novo Nordisk Investigational SiteDelawareOhio43015-
Novo Nordisk Investigational SiteCorvallisOregon97330-3737-
Novo Nordisk Investigational SitePortlandOregon97210-
Novo Nordisk Investigational SitePortlandOregon97239-
Novo Nordisk Investigational SiteLansdalePennsylvania19446-1002-
Novo Nordisk Investigational SiteNorristownPennsylvania19401-
Novo Nordisk Investigational SiteCharlestonSouth Carolina29407-
Novo Nordisk Investigational SiteMt. PleasantSouth Carolina29464-
Novo Nordisk Investigational SiteMurrells InletSouth Carolina29576-
Novo Nordisk Investigational SiteSpartanburgSouth Carolina29303-
Novo Nordisk Investigational SiteChattanoogaTennessee37404-
Novo Nordisk Investigational SiteAustinTexas78731-
Novo Nordisk Investigational SiteCarrolltonTexas75010-
Novo Nordisk Investigational SiteDallasTexas75225-
Novo Nordisk Investigational SiteDallasTexas75390-8858-
Novo Nordisk Investigational SiteFort WorthTexas76117-
Novo Nordisk Investigational SiteHoustonTexas77008-
Novo Nordisk Investigational SiteHoustonTexas77024-
Novo Nordisk Investigational SiteHoustonTexas77040-
Novo Nordisk Investigational SiteHoustonTexas77072-
Novo Nordisk Investigational SiteIrvingTexas75039-
Novo Nordisk Investigational SiteKatyTexas77450-
Novo Nordisk Investigational SiteSan AntonioTexas78245-
Novo Nordisk Investigational SiteSugar LandTexas77478-
Novo Nordisk Investigational SiteSugar LandTexas77479-
Novo Nordisk Investigational SiteAlexandriaVirginia22304-

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