Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT02229396
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.

Key Dates

Start date
Sep 4, 2014
Status verified
Dec 2018
Primary completion
Apr 26, 2016
Completion
Dec 28, 2017

Study Design

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

Arms

  • Experimental: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
  • Experimental: Exenatide Once Weekly 2 mg Alone
  • Active Comparator: Dapagliflozin Once Daily 10 mg Alone

Primary Outcome Measure

Change in HbA1c From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]

Locations (76)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35235-
Research SiteHuntsvilleAlabama35801-
Research SiteTuscumbiaAlabama35674-
Research SiteGlendaleArizona85306-
Research SiteTempeArizona85283-
Research SiteAnaheimCalifornia92801-
Research SiteChula VistaCalifornia91911-
Research SiteEl CajonCalifornia92020-
Research SiteFresnoCalifornia93720-
Research SiteLa MesaCalifornia91942-
Research SiteLong BeachCalifornia90807-
Research SiteLos AngelesCalifornia90057-
Research SiteMission HillsCalifornia91345-
Research SiteMontclairCalifornia91763-
Research SiteOceansideCalifornia92056-
Research SiteSan DiegoCalifornia92103-
Research SiteSan DiegoCalifornia92114-
Research SiteTustinCalifornia92780-
Research SiteVan NuysCalifornia91405-
Research SiteBoynton BeachFlorida33437-
Research SiteClearwaterFlorida33765-
Research SiteCoral GablesFlorida33134-
Research SiteFort LauderdaleFlorida33316-
Research SiteHialeahFlorida33012-
Research SiteJacksonvilleFlorida32256-
Research SiteJacksonvilleFlorida32277-
Research SiteMiamiFlorida33126-
Research SiteMiamiFlorida33133-
Research SiteMiamiFlorida33135-
Research SiteMiamiFlorida33142-
Research SiteMiamiFlorida33165-
Research SiteMiamiFlorida33175-
Research SiteMiamiFlorida33186-
Research SiteNorth Miami BeachFlorida33162-
Research SiteOrlandoFlorida32801-
Research SiteOrlandoFlorida32806-
Research SiteTampaFlorida33603-
Research SiteWillistonFlorida32696-
Research SiteChicagoIllinois60607-
Research SiteAvonIndiana46123-
Research SiteEvansvilleIndiana47714-
Research SiteFranklinIndiana46131-
Research SiteMuncieIndiana47304-
Research SiteNewtonKansas67114-
Research SiteMonroeLouisiana71201-
Research SiteHazelwoodMissouri63042-
Research SiteBellevueNebraska68005-
Research SiteLas VegasNevada89109-
Research SiteHaddon HeightsNew Jersey08035-
Research SiteBurlingtonNorth Carolina27215-
Research SiteGreensboroNorth Carolina27408-
Research SiteMooresvilleNorth Carolina28117-
Research SiteMorehead CityNorth Carolina28557-
Research SiteCincinnatiOhio45242-
Research SiteVandaliaOhio45377-
Research SiteMedfordOregon97504-
Research SitePhiladelphiaPennsylvania91307-
Research SiteCharlestonSouth Carolina29407-
Research SiteGreerSouth Carolina29651-
Research SiteSpartanburgSouth Carolina29303-
Research SiteSummervilleSouth Carolina29485-
Research SiteDakota DunesSouth Dakota57049-
Research SiteMemphisTennessee38119-
Research SiteDallasTexas75218-
Research SiteDallasTexas75230-
Research SiteHoustonTexas77074-
Research SiteHoustonTexas77079-
Research SiteHoustonTexas77090-
Research SitePearlandTexas77584-
Research SiteSan AntonioTexas78229-
Research SiteTomballTexas77375-
Research SiteClintonUtah84015-
Research SiteSalt Lake CityUtah84102-
Research SiteBurkeVirginia22015-
Research SiteManassasVirginia20110-
Research SiteRichmondVirginia23294-

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