An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT00643851
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, Once daily, 24 weeks
  • Metformin XR — DRUG
    Tablets, Oral, Once daily, 24 weeks

Study Details

The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied

Key Dates

Start date
Jun 30, 2008
Status verified
Jan 2023
Primary completion
Aug 31, 2009
Completion
Aug 31, 2009

Study Design

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

Arms

  • Experimental: Arm 1
    Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
  • Experimental: Arm 2
    Dapagliflozin (5 mg)
  • Active Comparator: Arm 3
    Metformin XR (500 mg up to 2000 mg)

Primary Outcome Measure

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]

Locations (44)

FacilityCityStateZIPSite coordinators
Greystone Medical Research, LlcBirminghamAlabama35242-
Winston Technology Research, LlcHaleyvilleAlabama35565-
Clinical Research Advantage, Inc.TempeArizona85282-
John Muir Physician Network Clinical Research CenterConcordCalifornia94520-
Southland Clinical Research Center, Inc.Fountain ValleyCalifornia92708-
Valley ResearchFresnoCalifornia93720-
Central Florida Clinical Trials, Inc.Altamonte SpringsFlorida32701-
Clinical Therapeutics CorporationCoral GablesFlorida33134-
Florida Research Network, LlcGainesvilleFlorida32605-
Fpa Clinical ResearchKissimmeeFlorida34741-
Nextphase Clinical Trials, Inc.MiamiFlorida33145-
Middle Georgia Drug Study Center, LlcPerryGeorgia31069-
Cedar Crosse Research CenterChicagoIllinois60607-
Deerbrook Medical AssociatesVernon HillsIllinois60061-
Jackson ClinicRolling ForkMississippi39159-
Mercy Medical Group/Dba Woodlake ResearchChesterfieldMissouri63017-
Hudson Valley Clinical Research CenterKingstonNew York12401-
Metrolina Medical ResearchCharlotteNorth Carolina28209-
Crescent Medical ResearchSalisburyNorth Carolina28144-
Community Health Care, Inc.Canal FultonOhio44614-
Wells Institute For Health AwarenessKetteringOhio45429-
Newark Physician AssociatesNewarkOhio43055-
Physician Research, Inc.ZanesvilleOhio43701-
Gilbert Medical Research, LlcBethanyOklahoma73008-
Integris Family Care South PennOklahoma CityOklahoma73159-
Integris Family Care YukonYukonOklahoma73099-
Willamette Valley Clinical StudiesEugeneOregon97404-
Commonwealth Primary Care, Pc / Fleetwood Clinical ResearchFleetwoodPennsylvania19522-
Biomedical Research Associates, LlcShippensburgPennsylvania17257-
Safe Harbor Clinical ResearchEast ProvidenceRhode Island02914-
Southeastern Research Associates, Inc.GreenvilleSouth Carolina29605-
Spartanburg Medical ResearchSpartanburgSouth Carolina29303-
Middle Tennessee Clinical ResearchFayettevilleTennessee37334-
Holston Medical GroupKingsportTennessee37660-
Endocrine AssociatesHoustonTexas77004-
Excel Clinical Research, LlcHoustonTexas77081-
Non-Invasive Cardiovascular, PaHoustonTexas77074-
Texas Center For Drug DevelopmentHoustonTexas77081-
Village Family PracticeHoustonTexas77024-
Inst. Of Clin. Research At The Diabetes Cntr. Of The SwMidlandTexas79705-
Hill Country Medical AssociatesNew BraunfelsTexas78130-
Southwest Clinical Research Center, LlcPearlandTexas77584-
Covenant Clinical Research, PaSan AntonioTexas78229-
S.A.M. Clinical Research CenterSan AntonioTexas78229-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Greystone Medical Research, Llc· Birmingham, ALWinston Technology Research, Llc· Haleyville, ALClinical Research Advantage, Inc.· Tempe, AZJohn Muir Physician Network Clinical Research Center· Concord, CASouthland Clinical Research Center, Inc.· Fountain Valley, CAValley Research· Fresno, CA

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