Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01606007
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saxagliptin — DRUG
    Tablets, Oral, 5mg , Once daily, 24 weeks
  • Metformin XR — DRUG
    Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
  • Dapagliflozin — DRUG
    Tablets, Oral, 10mg , Once daily, 24 weeks
  • Placebo matching with Dapagliflozin — DRUG
    Tablets, Oral, 0mg, Once daily, 24 weeks
  • Placebo matching with Saxagliptin — DRUG
    Tablets, Oral, 0mg, Once daily, 24 weeks

Study Details

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

Key Dates

Start date
Jul 31, 2012
Status verified
Mar 2017
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

Enrollment
1,282 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Saxagliptin+Metformin XR+Placebo
  • Active Comparator: Arm 2: Dapagliflozin+Metformin XR+Placebo
  • Experimental: Arm 3: Saxagliptin+Dapagliflozin+Metformin XR

Primary Outcome Measure

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 [ Time Frame: Baseline (Week 0) and at Week 24 ]

Locations (80)

FacilityCityStateZIPSite coordinators
Central Alabama ResearchBirminghamAlabama35209-
Central Alabama ResearchHomewoodAlabama35244-
Terence T. Hart, MdMuscle ShoalsAlabama35662-
International Institute Of Clinical ResearchOzarkAlabama36360-
Clinical Research AdvantageMesaArizona85206-
Elite Clinical Studies, LlcPhoenixArizona85018-
Genova Clinical ResearchTucsonArizona85704-
Aureus Research, Inc.Little RockArkansas72211-
Medical Investigations, Inc.Little RockArkansas72205-
Southland Clinical Research Center, Inc.Fountain ValleyCalifornia92708-
Torrance Clinical ResearchLomitaCalifornia90717-
National Research InstLos AngelesCalifornia90057-
Providence Clinical ResearchNorth HollywoodCalifornia91606-
Diabetes Medical Center Of CaliforniaNorthridgeCalifornia91325-
Mehrdad Kevin Ariani Md, Inc.NorthridgeCalifornia91325-
Lucita M. Cruz,Md.,Inc.NorwalkCalifornia90650-
Center For Clinical Trials, Llc.ParamountCalifornia90723-
Center For Clinical Trials Of Sacramento, Inc.SacramentoCalifornia95823-
Trinitas Research, IncSan JoseCalifornia95116-
Orange County Research CenterTustinCalifornia92780-
Clinical Research AdvantageColorado SpringsColorado80906-
Infocus Clinical ResearchDenverColorado80211-
Lynn Institute Of DenverDenverColorado80246-
Southeast Clinical Research, LlcChieflandFlorida32626-
Clinical Therapeutics CorporationCoral GablesFlorida33134-
Southeast Clinical Research, LlcJacksonvilleFlorida32216-
Fpa Clinical ResearchKissimmeeFlorida34741-
Advanced Pharma Cr, LlcMiamiFlorida33136-
Clinical Research Of Miami, Inc.MiamiFlorida33126-
Newphase Clinical Trials, Inc.Miami BeachFlorida33140-
Omega Research Consultants, LlcOrlandoFlorida32804-
Palm Harbor Medical AssociatesPalm HarborFlorida34684-
Andres Patron, Do PaPembroke PinesFlorida33026-
Endocrine Research Solutions, Inc.RoswellGeorgia30076-
Cedar Crosse Research CenterChicagoIllinois60607-4559-
Deerbrook Medical AssociatesVernon HillsIllinois60061-
Clinical Research AdvantageCouncil BluffsIowa51503-
Horizon Research Group Of Opelousas, LlcEuniceLouisiana70535-
Associated Internal Medicine SpecialistsBattle CreekMichigan49015-
Harris And Associates, P.C.DetroitMichigan48235-
Patterson Medical ClinicFlorissantMissouri63031-
Bellevue Family PracticeBellevueNebraska68005-
Clinical Research AdvantageElkhornNebraska68022-
Clinical Research AdvantageFremontNebraska68025-
Clinical Research AdvantageOmahaNebraska68130-
South Jersey Medical Associates, P.A.BlackwoodNew Jersey08012-
Central Jersey Health And Medical ResearchElizabethNew Jersey07205-
Southgate Medical GroupWest SenecaNew York14224-
Metrolina Internal MedicineCharlotteNorth Carolina28204-
Triad Clinical Trials, LlcGreensboroNorth Carolina27410-
Diabetes & Endocrinology ConsultantsMorehead CityNorth Carolina28557-
Pmg Research Of Winston-Salem, LlcWinston-SalemNorth Carolina27103-
Daystar Clinical Resarch, Inc.AkronOhio44313-
Sterling Research Grp, Ltd.CincinnatiOhio45246-
Rapid Medical Research, Inc.ClevelandOhio44122-
Primed Clinical ResearchDaytonOhio45419-
Physicians Research, Inc.ZanesvilleOhio43701-
Lynn Institute Of NormanNormanOklahoma73069-
Willamette Valley Clinical StudiesEugeneOregon97404-
Oregon Clinical ResearchPortlandOregon97220-
Heritage Valley Medical GroupBeaverPennsylvania15009-
Wellmon Family PracticeShippensburgPennsylvania17257-
Tlm Medical ServicesColumbiaSouth Carolina29204-
Palmetto Clinical Trial Services LlcFountain InnSouth Carolina29644-
Holston Medical GroupBristolTennessee37620-
Holston Medical GroupKingsportTennessee37660-
Pmg Research Of KnoxvilleKnoxvilleTennessee37912-
Arlington Family Research Center, Inc.ArlingtonTexas76012-
Padre Coast Clinical ResearchCorpus ChristiTexas78404-
Dallas Diabetes & Endocrine CenterDallasTexas75230-2548-
Excel Clinical Research, LlcHoustonTexas77035-
North Hills Medical Research, Inc.North Richland HillsTexas76180-
Med-Olam Clinical ResearchPasadenaTexas77504-
Sam Clinical Research CenterSan AntoinioTexas78229-
Covenant Clinical Research, PaSan AntonioTexas78229-
Hillcrest Family Health CenterWacoTexas76710-
Val R. Hansen, M.D.BountifulUtah84010-
Highland Clinical ResearchSalt Lake CityUtah84124-
Southwestern Vermont Med CntrBenningtonVermont05201-
Hampton Roads Center For Clinical Research, Inc.SuffolkVirginia23435-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Central Alabama Research· Birmingham, ALCentral Alabama Research· Homewood, ALTerence T. Hart, Md· Muscle Shoals, ALInternational Institute Of Clinical Research· Ozark, ALClinical Research Advantage· Mesa, AZElite Clinical Studies, Llc· Phoenix, AZ

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