A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

Part of paid clinical trials in Saraland, Alabama.

Sponsor
AstraZeneca
Study ID
NCT02681094
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    5mg, orally, Green, plain, diamond-shaped, film-coated tablet
  • Placebo for Dapagliflozin — DRUG
    Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
  • Saxagliptin — DRUG
    5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
  • Placebo for Saxagliptin — DRUG
    Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet

Study Details

The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.

Key Dates

Start date
Feb 26, 2016
Status verified
Sep 2018
Primary completion
Jul 15, 2017
Completion
Jul 15, 2017

Study Design

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

Arms

  • Active Comparator: Saxagliptin+Dapagliflozin+Metformin
    5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin
  • Active Comparator: Dapagliflozin+Saxagliptin placebo+Metformin
    5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo
  • Active Comparator: Saxagliptin+Dapagliflozin placebo+metformin
    5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo

Primary Outcome Measure

Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and week 24 ]

Locations (48)

FacilityCityStateZIPSite coordinators
Research SiteSaralandAlabama36571-
Research SiteFresnoCalifornia93702-
Research SiteHarbor CityCalifornia90710-
Research SiteHawaiian GardensCalifornia90716-
Research SiteLancasterCalifornia93534-
Research SiteLos AngelesCalifornia90057-
Research SiteMontclairCalifornia91763-
Research SitePomonaCalifornia91767-
Research SiteSpring ValleyCalifornia91978-
Research SiteVallejoCalifornia94592-
Research SiteDenverColorado80220-
Research SiteNorthglennColorado80234-
Research SiteWheat RidgeColorado80033-
Research SiteWaterburyConnecticut06708-
Research SiteCooper CityFlorida33024-
Research SiteDoralFlorida33166-
Research SiteHialeahFlorida33012-
Research SiteMiamiFlorida33176-
Research SiteMiamiFlorida33186-
Research SiteMiami LakesFlorida33016-
Research SiteBufordGeorgia30518-
Research SiteChicagoIllinois60607-
Research SiteHazel CrestIllinois60429-
Research SiteNew OrleansLouisiana70115-
Research SiteZacharyLouisiana70791-
Research SiteBiloxiMississippi39531-
Research SiteFlorissantMissouri63031-
Research SiteAlbanyNew York12203-
Research SiteThe BronxNew York10459-
Research SiteAshevilleNorth Carolina28801-
Research SiteMooresvilleNorth Carolina28117-
Research SiteFargoNorth Dakota58103-
Research SiteColumbusOhio43201-
Research SiteMaumeeOhio43537-
Research SiteEast ProvidenceRhode Island02914-
Research SiteWest ColumbiaSouth Carolina29169-
Research SiteDallasTexas75208-
Research SiteDallasTexas75230-
Research SiteEl PasoTexas79935-
Research SiteFort WorthTexas76132-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77036-
Research SiteHoustonTexas77040-
Research SiteOdessaTexas79761-
Research SiteSugar LandTexas77479-
Research SiteWacoTexas76710-
Research SiteSalt Lake CityUtah84102-
Research SiteNorfolkVirginia23510-

Find similar trials in Saraland, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Saraland, ALResearch Site· Fresno, CAResearch Site· Harbor City, CAResearch Site· Hawaiian Gardens, CAResearch Site· Lancaster, CAResearch Site· Los Angeles, CA

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