A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD

Part of paid clinical trials in Peoria, Arizona.

Sponsor
AstraZeneca
Study ID
NCT02547935
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus, CKD and Albuminuria

Eligibility Criteria

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

Interventions

Study Details

The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)

Key Dates

Start date
Sep 21, 2015
Status verified
Jul 2019
Primary completion
May 18, 2018
Completion
May 18, 2018

Study Design

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

Arms

  • Experimental: Dapagliflozin 10mg
    Tablets administered orally once daily for 24 weeks
  • Experimental: Dapagliflozin 10mg + Saxagliptin 2.5mg
    Tablets administered orally once daily for 24 weeks
  • Placebo Comparator: Placebo
    Tablets administered orally once daily for 24 weeks

Primary Outcome Measure

Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (37)

FacilityCityStateZIPSite coordinators
Research SitePeoriaArizona85381-
Research SiteChula VistaCalifornia91910-
Research SiteConcordCalifornia94520-
Research SiteEl CentroCalifornia92243-
Research SiteLa MesaCalifornia92123-
Research SiteLong BeachCalifornia90807-
Research SiteLos GatosCalifornia95032-
Research SiteNorth HollywoodCalifornia91606-
Research SiteRiversideCalifornia92505-
Research SiteSan DiegoCalifornia92111-
Research SiteSan DimasCalifornia91773-
Research SiteHollywoodFlorida33024-
Research SiteMiamiFlorida33126-
Research SiteNew Port RicheyFlorida34652-
Research SitePalm HarborFlorida34684-
Research SitePompano BeachFlorida33060-
Research SiteAugustaGeorgia30909-
Research SiteMeridianIdaho83642-
Research SiteChicagoIllinois60643-
Research SiteBangorMaine04401-
Research SiteKansas CityMissouri64111-
Research SiteLas VegasNevada89148-
Research SiteSpringfield GardensNew York11413-
Research SiteThe BronxNew York10459-
Research SiteGreensboroNorth Carolina27408-
Research SiteMorehead CityNorth Carolina28557-
Research SiteRocky MountNorth Carolina27804-
Research SitePhiladelphiaPennsylvania19107-
Research SiteGreenvilleSouth Carolina29605-
Research SiteBrownsvilleTexas78520-
Research SiteCypressTexas77429-
Research SiteHoustonTexas77004-
Research SiteSan AntonioTexas78215-
Research SiteSugar LandTexas77479-
Research SiteSalt Lake CityUtah84124-
Research SiteBurkeVirginia22015-
Research SiteRichmondVirginia23219-

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