Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Part of paid clinical trials in Concord, California.

Sponsor
AstraZeneca
Study ID
NCT02460978
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Key Dates

Start date
Jul 8, 2015
Status verified
Feb 2019
Primary completion
Sep 2, 2017
Completion
Apr 18, 2018

Study Design

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

Arms

  • Experimental: Dapagliflozin 5 mg
    Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
  • Experimental: Dapagliflozin 10 mg
    Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
  • Placebo Comparator: Placebo
    Placebo tablet orally, once daily for 52 weeks

Primary Outcome Measure

Adjusted Mean Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and 24 weeks ]

Locations (47)

FacilityCityStateZIPSite coordinators
Research SiteConcordCalifornia94520-
Research SiteFresnoCalifornia93720-
Research SiteLos AngelesCalifornia90057-
Research SiteOrangeCalifornia92868-
Research SiteSan MateoCalifornia94401-
Research SiteSan RamonCalifornia94583-
Research SiteWalnut CreekCalifornia94598-
Research SiteGoldenColorado80401-
Research SiteNewarkDelaware19713-
Research SiteBradentonFlorida34201-
Research SiteClearwaterFlorida33756-
Research SiteFort LauderdaleFlorida33312-
Research SiteJacksonvilleFlorida32216-
Research SiteMiamiFlorida33156-
Research SiteMiami SpringsFlorida33166-
Research SiteSt. PetersburgFlorida33709-
Research SiteTampaFlorida33634-
Research SiteAtlantaGeorgia30308-
Research SiteAtlantaGeorgia30318-
Research SiteRoswellGeorgia30076-
Research SiteChicagoIllinois60607-
Research SiteChicagoIllinois60611-
Research SiteDes MoinesIowa50314-
Research SiteOverland ParkKansas66209-
Research SiteLexingtonKentucky40502-
Research SiteLexingtonKentucky40503-
Research SiteKalamazooMichigan49008-
Research SiteEdinaMinnesota55435-
Research SiteJefferson CityMissouri65109-
Research SiteSt LouisMissouri63110-
Research SiteRenoNevada89511-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteAlbanyNew York12208-
Research SiteFlushingNew York11355-
Research SiteMineolaNew York11501-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10029-
Research SitePhiladelphiaPennsylvania19107-4824-
Research SiteAmarilloTexas79106-
Research SiteAustinTexas78731-
Research SiteDallasTexas75231-
Research SiteEdinburgTexas78539-
Research SiteMesquiteTexas74194-
Research SiteSan AntonioTexas78229-
Research SiteSan AntonioTexas78258-
Research SiteBenningtonVermont05201-
Research SiteFederal WayWashington98003-

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