Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Part of paid clinical trials in Mesa, Arizona.

Sponsor
AstraZeneca
Study ID
NCT02284893
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Saxagliptin — DRUG
    administered orally once daily
  • Dapagliflozin — DRUG
    administered orally once daily
  • Sitagliptin — DRUG
    administered orally once daily
  • Placebo matching with Saxagliptin — DRUG
    administered orally once daily
  • Placebo matching with Dapagliflozin — DRUG
    administered orally once daily
  • Placebo matching with Sitagliptin — DRUG
    administered orally once daily

Study Details

Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Key Dates

Start date
Sep 9, 2014
Status verified
May 2018
Primary completion
Sep 20, 2016
Completion
Sep 20, 2016

Study Design

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

Arms

  • Experimental: A1:Saxagliptin / Placebo + Dapagliflozin / Placebo
    Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily)
  • Experimental: A2: Sitagliptin / placebo
    Sitagliptin 100 mg and matching placebo 0 mg (once daily)

Primary Outcome Measure

Mean Change in HbA1c [ Time Frame: Baseline (randomization) to Week 26 ]

Locations (40)

FacilityCityStateZIPSite coordinators
Research SiteMesaArizona85206-
Research SiteMesaArizona85213-
Research SitePhoenixArizona85020-
Research SiteLittle RockArkansas72205-
Research SiteHuntington BeachCalifornia92648-
Research SiteHuntington ParkCalifornia90255-
Research SiteLomitaCalifornia90717-
Research SiteLos AngelesCalifornia90057-
Research SiteNorthridgeCalifornia91325-
Research SiteNorwalkCalifornia90650-
Research SiteParamountCalifornia90723-
Research SiteSacramentoCalifornia95823-
Research SiteTarzanaCalifornia91356-
Research SiteTustinCalifornia92780-
Research SiteGoldenColorado80401-
Research SiteCoral GablesFlorida33134-
Research SiteKissimmeeFlorida34744-
Research SiteMiamiFlorida33015-
Research SiteMiamiFlorida33135-
Research SiteMiamiFlorida33174-
Research SiteMiami BeachFlorida33140-
Research SitePalm HarborFlorida34684-
Research SitePembroke PinesFlorida33026-
Research SiteChicagoIllinois60634-
Research SiteCouncil BluffsIowa51503-
Research SiteCrestview HillsKentucky41017-
Research SiteCharlotteNorth Carolina28204-
Research SiteMorehead CityNorth Carolina28557-
Research SiteSalisburyNorth Carolina28144-
Research SiteNormanOklahoma73069-
Research SiteColumbiaSouth Carolina29204-
Research SiteBristolTennessee37620-
Research SiteDallasTexas75230-
Research SiteHoustonTexas77081-
Research SiteNorth Richland HillsTexas76180-
Research SitePasadenaTexas77504-
Research SiteSan AntonioTexas78229-
Research SiteManassasVirginia20110-
Research SiteSuffolkVirginia23452-
Research SiteKenoshaWisconsin53142-

Find similar trials in Mesa, AZ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Mesa, AZResearch Site· Phoenix, AZResearch Site· Little Rock, ARResearch Site· Huntington Beach, CAResearch Site· Huntington Park, CAResearch Site· Lomita, CA

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