A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

Part of paid clinical trials in Bayou La Batre, Alabama.

Sponsor
AstraZeneca
Study ID
NCT00263276
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
  • dapagliflozin — DRUG
    Tablets, Oral, 5 mg, Once daily, 12 weeks.
  • dapagliflozin — DRUG
    Tablets, Oral, 10 mg, Once daily, 12 weeks.
  • dapagliflozin — DRUG
    Tablets, Oral, 20 mg, Once daily, 12 weeks.
  • dapagliflozin — DRUG
    Tablets, Oral, 50 mg, Once daily, 12 weeks.
  • placebo — DRUG
    Tablets, Oral, 0 mg, Once daily, 12 weeks.
  • metformin — DRUG
    Tablets, Oral, \>/= 1500 mg, Once daily, 12 weeks.

Study Details

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

Key Dates

Start date
Dec 31, 2005
Status verified
Nov 2016
Primary completion
Feb 28, 2007
Completion
Feb 28, 2007

Study Design

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

Arms

  • Experimental: Arm 1
  • Experimental: Arm 2
  • Experimental: Arm 3
  • Experimental: Arm 4
  • Experimental: Arm 5
  • Placebo Comparator: Arm 6
  • Active Comparator: Arm 7

Primary Outcome Measure

Mean change from baseline in HbA1c compared to placebo. [ Time Frame: at 12 weeks ]

Locations (111)

FacilityCityStateZIPSite coordinators
Local InstitutionBayou La BatreAlabama--
Local InstitutionBirminghamAlabama--
Local InstitutionHuntsvilleAlabama--
Local InstitutionMobileAlabama--
Local InstitutionChandlerArizona--
Local InstitutionTucsonArizona--
Local InstitutionFayettevilleArkansas--
Local InstitutionHot SpringsArkansas--
Local InstitutionBeverly HillsCalifornia--
Local InstitutionLong BeachCalifornia--
Local InstitutionLos GatosCalifornia--
Local InstitutionMission ViejoCalifornia--
Local InstitutionOrangeCalifornia--
Local InstitutionRedondo BeachCalifornia--
Local InstitutionSan DiegoCalifornia--
Local InstitutionTorranceCalifornia--
Local InstitutionColorado SpringsColorado--
Local InstitutionDenverColorado--
Local InstitutionBoynton BeachFlorida--
Local InstitutionBrandonFlorida--
Local InstitutionDelray BeachFlorida--
Local InstitutionHolly HillFlorida--
Local InstitutionJacksonvilleFlorida--
Local InstiuttionJacksonvilleFlorida--
Local InstitutionNew Port RicheyFlorida--
Local InstitutionOrlandoFlorida--
Local InstitutionOrmond BeachFlorida--
Local InstitutionAugustaGeorgia--
Local InstitutionBlue RidgeGeorgia--
Local InstitutionHonoluluHawaii--
Local InstitutionIndianapolisIndiana--
Local InstitutionLafayetteIndiana--
Local InstitutionArkansas CityKansas--
Local InstitutionBaton RougeLouisiana--
Local InstitutionColumbiaMaryland--
Local InstitutionElktonMaryland--
Local InstitutionSudburyMassachusetts--
Local InstitutionWorcesterMassachusetts--
Local InstitutionDearbornMichigan--
Local InstitutionRoyal OakMichigan--
Local InstitutionBrooklyn CenterMinnesota--
Local InsitutionEdinaMinnesota--
Local InstitutionMinneapolisMinnesota--
Local InstitutionHattiesburgMississippi--
Local InstitutionJacksonMississippi--
Local InstitutionChesterfieldMissouri--
Local InstitutionKansas CityMissouri--
Local InstitutionSt LouisMissouri--
Local InstitutionScottsbluffNebraska--
Local InstitutionNorth Las VegasNevada--
Local InstitutionAlbuquerqueNew Mexico--
Local InstitutionLos AlamosNew Mexico--
Local InstitutionAlbanyNew York--
Local InstitutionBronxvilleNew York--
Local InstitutionCamillusNew York--
Local InstitutionCooperstownNew York--
Local InstiutionNew Hyde ParkNew York--
Local InstitutionWest SenecaNew York--
Local InstitutionCharlotteNorth Carolina--
Local InstitutionHigh PointNorth Carolina--
Local InstitutionMorehead CityNorth Carolina--
Local InstitutionRaleighNorth Carolina--
Local InstitutionWilmingtonNorth Carolina--
Local InstitutionAkronOhio--
Local InstitutionBeachwoodOhio--
Local InstitutionCincinnatiOhio--
Local InstitutionClevelandOhio--
Local InstitutionDaytonOhio--
Local InstitutionMogadoreOhio--
Local InstitutionNewarkOhio--
Local InstitutionZanesvilleOhio--
Local InstitutionBethanyOklahoma--
Local InstitutionYukonOklahoma--
Local InstitutionBendOregon--
Local InstitutionEugeneOregon--
Local InstitutionHillsboroOregon--
Local InstitutionPortlandOregon--
Local InstitutionBensalemPennsylvania--
Local InstitutionFeastervillePennsylvania--
Local InstitutionLevittownPennsylvania--
Local InstitutionMorrisvillePennsylvania--
Local InstitutionReadingPennsylvania--
Local InstitutionCumberlandRhode Island--
Local InstitutionJohnstonRhode Island--
Local InstitutionAndersonSouth Carolina--
Local InstitutionSimpsonvilleSouth Carolina--
Local InstitutionSummervilleSouth Carolina--
Local InstitutionTaylorsSouth Carolina--
Local InstitutionRapid CitySouth Dakota--
Local InstitutionMemphisTennessee--
Local InstitutionNashvilleTennessee--
Local InstitutionSelmerTennessee--
Local InstitutionAustinTexas--
Local InstitutionBellaireTexas--
Local InstitutionBryanTexas--
Local InstitutionEl PasoTexas--
Local InstitutionHoustonTexas--
Local InstitutionIrvingTexas--
Local InstitutionSan AntonioTexas--
Local InstitutionSalt Lake CityUtah--
Local InstitutionBurkeVirginia--
Local InstitutionHamptonVirginia--
Local InstitutionNorfolkVirginia--
Local InstitutionRichmondVirginia--
Local InstitutionVirginia BeachVirginia--
Local InstitutionEdmondsWashington--
Local InstitutionRentonWashington--
Local InstitutionSpokaneWashington--
Local InstitutionVancouverWashington--
Local InstitutionMilwaukeeWisconsin--
Local InstitutionWest AllisWisconsin--

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