Add-on to Thiazolidinedione (TZD) Failures

Part of paid clinical trials in Anniston, Alabama.

Sponsor
AstraZeneca
Study ID
NCT00683878
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
  • Dapagliflozin — DRUG
    Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
  • Placebo matching Dapagliflozin — DRUG
    Tablets, Oral, 0 mg, once daily, up to 48 weeks
  • Thiazolidinedione (Pioglitazone) — DRUG
    Tablets, ≥ 30 mg, Once daily, up to 48 weeks

Study Details

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

Key Dates

Start date
Jul 31, 2008
Status verified
Jan 2017
Primary completion
Jan 31, 2010
Completion
Jun 30, 2010

Study Design

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

Arms

  • Experimental: Arm 1
  • Experimental: Arm 2
  • Placebo Comparator: Arm 3

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 (57)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LlcAnnistonAlabama36207-
IicrOzarkAlabama36360-
43rd Medical Associates, P.C.PhoenixArizona85051-
Clinical Research Advantage Inc / Desert Clinical Res, LlcTempeArizona85282-
Clinical Research Advantage, IncTempeArizona85282-
Little Rock Family Practice ClinicLittle RockArkansas72205-
Searcy Medical CenterSearcyArkansas72143-
Clinical Innovations, Inc.Costa MesaCalifornia92626-
Marin Endocrine Care And Research, Inc.GreenbraeCalifornia94904-
Torrance Clinical ResearchLomitaCalifornia90717-
Randall Shue, D.O.Los AngelesCalifornia90023-
Diabetes Medical Center Of CaliforniaNorthridgeCalifornia91325-
Desert Medical AdvancesPalm DesertCalifornia92260-
Avastra Clinical TrialsRedlandsCalifornia92373-
Sierra Clinical ResearchRosevilleCalifornia95661-
Ritchken & First M.D.'SSan DiegoCalifornia92117-
Advantage Clinical ResearchSanta AnaCalifornia92701-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Diabetes Research CenterTustinCalifornia92780-
Aurora Family Medicine Center, P.C.AuroraColorado80012-
Denver Internal MedicineDenverColorado80209-
Central Florida Clinical TrialsAltamonte SpringsFlorida32701-
Health First Clinical Research Group, Inc.ChipleyFlorida32428-
Clinical Therapeutics CorporationCoral GablesFlorida33134-
Westside Center For Clinical ResearchJacksonvilleFlorida32205-
Panhandle Family Care AssociatesMariannaFlorida32446-
Baptist Diabetes Associates, PaMiamiFlorida33156-
Suncoast Clinical Res Inc.New Port RicheyFlorida34652-
Stone Mountain Clinical ResearchStone MountainGeorgia30088-
Cedar Crosse Research CenterChicagoIllinois60607-
Northwest Indiana Center For Clinical ResearchValparaisoIndiana46383-
Professional Research Network Of KansasWichitaKansas67203-
St. Mary'S Center For Diabetes And EndocrinologyGrand RapidsMichigan49503-
Endocrine Research AssociatesJacksonMississippi39216-
Olive Branch Family Medical CenterOlive BranchMississippi38654-
Danny W. Jackson P.A.Rolling ForkMississippi39159-
Association Of International ProfessionalsLas VegasNevada89101-
Physicians Research CenterToms RiverNew Jersey08755-
Finger Lakes Clinical ResearchRochesterNew York14618-
Metrolina Internal MedicineCharlotteNorth Carolina28204-
The Center For Nutrition & Preventive Medicine, PllcCharlotteNorth Carolina28277-
Northstate Clinical ResearchLenoirNorth Carolina28645-
New Hanover Medical ResearchWilmingtonNorth Carolina28401-
Providence Health Partners - Center For Clinical ResearchDaytonOhio45439-
Physician Research, Inc.ZanesvilleOhio43701-
Family Medical AssociatesLevittownPennsylvania19056-
Banksville Medical, PcPittsburghPennsylvania15216-
Brookside Family Practice & PediatricsPottstownPennsylvania19464-
Columbia Clinical Research, Inc.ColumbiaSouth Carolina29201-
Southeastern Research Associates, Inc.TaylorsSouth Carolina29687-
Holston Medical GroupKingsportTennessee37660-
Dallas Diabetes & Endocrine CenterDallasTexas75230-
Office Of Dr. Michelle Zaniewski SinghHoustonTexas77090-
Village Family PracticeHoustonTexas77024-
Diabetes & Glandular Disease Research Assoc,, Inc.San AntonioTexas78229-
Tidewater Integrated Medical ResearchVirginia BeachVirginia23454-
William L. Gray, MdSpokaneWashington99216-

Find similar trials in Anniston, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Pinnacle Research Group, Llc· Anniston, ALIicr· Ozark, AL43rd Medical Associates, P.C.· Phoenix, AZClinical Research Advantage Inc / Desert Clinical Res, Llc· Tempe, AZClinical Research Advantage, Inc· Tempe, AZLittle Rock Family Practice Clinic· Little Rock, AR

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