Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
AstraZeneca
Study ID
NCT02268214
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
Nov 11, 2014
Status verified
Aug 2018
Primary completion
Jan 4, 2017
Completion
Aug 25, 2017

Study Design

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

Arms

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

Primary Outcome Measure

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

Locations (36)

FacilityCityStateZIPSite coordinators
Research SiteLittle RockArkansas72205-
Research SiteEncinoCalifornia91436-
Research SiteLa MesaCalifornia91942-
Research SiteSan DiegoCalifornia92161-
Research SiteTarzanaCalifornia91356-
Research SiteTorranceCalifornia90502-
Research SiteAuroraColorado80045-
Research SiteDenverColorado80220-
Research SiteCooper CityFlorida33024-
Research SiteJacksonvilleFlorida32258-
Research SiteMiamiFlorida33136-
Research SitePort OrangeFlorida32127-
Research SiteIdaho FallsIdaho83404-7596-
Research SiteDes MoinesIowa50314-
Research SiteLouisvilleKentucky40213-
Research SitePortlandMaine04101-
Research SiteHyattsvilleMaryland20782-
Research SiteRockvilleMaryland20852-
Research SiteKalamazooMichigan49008-
Research SiteMinneapolisMinnesota55416-
Research SiteChesterfieldMissouri63017-
Research SiteLas VegasNevada89148-
Research SiteAlbanyNew York12206-
Research SiteBuffaloNew York14215-
Research SiteAshevilleNorth Carolina28803-
Research SiteChapel HillNorth Carolina27517-
Research SiteGreenvilleNorth Carolina27834-
Research SiteMorehead CityNorth Carolina28557-
Research SiteLanghornePennsylvania19047-
Research SiteKingsportTennessee37660-
Research SiteNashvilleTennessee37212-
Research SiteAmarilloTexas79106-
Research SiteDallasTexas75230-
Research SiteHoustonTexas77090-
Research SiteSalt Lake CityUtah84108-
Research SiteOlympiaWashington98502-

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