Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes

Part of paid clinical trials in Ozark, Alabama.

Sponsor
AstraZeneca
Study ID
NCT00859898
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 77 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 10 mg, once daily, 24 weeks
  • Metformin XR — DRUG
    Tablets, Oral, up to 2000 mg, once daily, 24 weeks
  • Metformin XR — DRUG
    Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
  • dapagliflozin matching Placebo — DRUG
    Tablets
  • metformin HCl Modified Release matching Placebo — DRUG
    Tablets

Study Details

The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study

Key Dates

Start date
Apr 30, 2009
Status verified
May 2016
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

Enrollment
1,093 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin + Metformin XR
    Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
  • Experimental: Dapagliflozin + Placebo
    Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks. Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
  • Active Comparator: Metformin XR + Placebo
    Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks

Primary Outcome Measure

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants [ Time Frame: Week 24 ]

Locations (64)

FacilityCityStateZIPSite coordinators
International Institute Of Clinical ResearchOzarkAlabama36360-
Clinical Research Advantage, Inc.TempeArizona85282-
Clinical Research Advantage, Inc./Mesa Family Med Ctr, PcTempeArizona85282-
John Muir Physician Network Clinical Research CenterConcordCalifornia94520-
Encompass Clinical Research-North CoastEncinitasCalifornia92024-
Southland Clinical Research Center, Inc.Fountain ValleyCalifornia92708-
Valley ResearchFresnoCalifornia93720-
Del Rosario Medical Clinic, Inc.Huntington ParkCalifornia90255-
Irvine Center For Clinical Research, Inc.IrvineCalifornia92618-
Pacific Sleep Medicine Services (Avastra Clinical Trials)RedlandsCalifornia92373-
Orange County Research CenterTustinCalifornia92780-
Lynn Institute Of The RockiesColorado SpringsColorado80907-
Radiant Research, Inc.DenverColorado80239-
Clinical Therapeutics CorporationCoral GablesFlorida33134-
Baptist Diabetes AssociatesMiamiFlorida33156-
Nextphase Clinical Trials, Inc.MiamiFlorida33145-
Metabolic Research Institute, Inc.West Palm BeachFlorida33401-
Lake Hartwell Family MedicineHartwellGeorgia30643-
Middle Georgia Drug Study Center, LlcPerryGeorgia31069-
Northwest Clinical TrialsBoiseIdaho83704-
Provident Clinical ResearchAddisonIllinois60101-
Cedar Crosse Research CenterChicagoIllinois60607-
Deerbrook Medical AssociatesVernon HillsIllinois60061-
Physicians Research GroupIndianapolisIndiana46250-
Borgess Research InstituteKalamazooMichigan49048-
Olive Branch Family Medical CenterOlive BranchMississippi38654-
Clinilabs, Inc.New YorkNew York10019-
Metrolina Medical ResearchCharlotteNorth Carolina28209-
PharmquestGreensboroNorth Carolina27408-
Crescent Medical ResearchSalisburyNorth Carolina28144-
Community Health Care, Inc.Canal FultonOhio44614-
Holzer Clinic, IncGallipolisOhio45631-
Wells Institute For Health AwarenessKetteringOhio45429-
Newark Physician AssociatesNewarkOhio43055-
Daniel G. Williams, MdPerrysburgOhio43551-
Physician Research, Inc.ZanesvilleOhio43701-
Gilbert Medical Research, LlcBethanyOklahoma73008-
Tulsa Clinical Research, LlcTulsaOklahoma74104-
Integris Family Care YukonYukonOklahoma73099-
Williamette Valley Clinical StudiesEugeneOregon97404-
Dingmans MedicalDingmans FerryPennsylvania18328-
Integrated Medical Group Pc/Fleetwood Clinical ResearchFleetwoodPennsylvania19522-
Wellmon Family PracticeShippensburgPennsylvania17257-
Safe Harbor Clinical ResearchEast ProvidenceRhode Island02914-
Southeastern Research Associates, Inc.GreenvilleSouth Carolina29605-
Holston Medical GroupBristolTennessee37620-
Parkway Medical GroupFayettevilleTennessee37334-
Holston Medical GroupKingsportTennessee37660-
Southwind Medical SpecialistsMemphisTennessee38125-
Dallas Diabetes & Endocrine CenterDallasTexas75230-
Endocrine AssociatesHoustonTexas77004-
Excel Clinical ResearchHoustonTexas77081-
Juno Research, Llc.HoustonTexas77036-
Non-Invasive Cardiovascular, PaHoustonTexas77074-
Texas Center For Drug DevelopmentHoustonTexas77081-
Village Family PracticeHoustonTexas77024-
Midland Clinical Research CenterMidlandTexas79707-
Hill Country Medical AssociatesNew BraunfelsTexas78130-
Covenant Clinical Research, PaSan AntonioTexas78229-
S.A.M. Clinical Research CenterSan AntonioTexas78229-
Avastra Clinical TrialsMidvaleUtah84047-
Seven Corners Medical CenterFalls ChurchVirginia22044-
Tidewater Integrated Medical ResearchVirginia BeachVirginia23454-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Ozark, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
International Institute Of Clinical Research· Ozark, ALClinical Research Advantage, Inc.· Tempe, AZClinical Research Advantage, Inc./Mesa Family Med Ctr, Pc· Tempe, AZJohn Muir Physician Network Clinical Research Center· Concord, CAEncompass Clinical Research-North Coast· Encinitas, CASouthland Clinical Research Center, Inc.· Fountain Valley, CA

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