A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Part of paid clinical trials in Tempe, Arizona.

Sponsor
AstraZeneca
Study ID
NCT00528879
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
  • Placebo — DRUG
    Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
  • Metformin — DRUG
    Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Study Details

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Key Dates

Start date
Sep 30, 2007
Status verified
Sep 2015
Primary completion
Nov 30, 2008
Completion
May 31, 2010

Study Design

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

Arms

  • Placebo Comparator: Placebo + Metformin
    Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
  • Experimental: Dapagliflozin, 2.5 mg + Metformin
    Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
  • Experimental: Dapagliflozin, 5 mg + Metformin
    Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
  • Experimental: Dapagliflozin, 10 mg + Metformin
    Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

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 (28)

FacilityCityStateZIPSite coordinators
Clinical Research Advantage / Desert Clinical Res, LlcTempeArizona85282-
Medical Group Of EncinoEncinoCalifornia91436-
Valley ResearchFresnoCalifornia93720-
Randall Shue, D.O.Los AngelesCalifornia90023-
Diabetes Medical Center Of CaliforniaNorthridgeCalifornia91325-
Ritchken & First M.D.'SSan DiegoCalifornia92117-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Raikhel, MarinaTorranceCalifornia90505-
Express Care Clinical ResColorado SpringsColorado80909-
Denver Internal MedicineDenverColorado80209-
New West PhysiciansGoldenColorado80401-
Central Florida Clinical Trials, Inc.Altamonte SpringsFlorida32701-
Family Care Associates Of Nw FloridaChipleyFlorida32428-
Health Partners Research FoundationMinneapolisMinnesota56440-
Woodlake ResearchChesterfieldMissouri63017-
Nevada Alliance Against DiabetesLas VegasNevada89101-
Diabetes & Endocrinology Consultants, PcMorehead CityNorth Carolina28557-
Newark Physician AssociatesNewarkOhio43055-
Integris Family Care S. PennOklahoma CityOklahoma73159-
Cumberland Valley Endocrinology Center, LlcCarlislePennsylvania17013-
Banksville Medical PcPittsburghPennsylvania15216-
Palmetto Clinical ResearchSummervilleSouth Carolina29485-
Southeastern Research AssocTaylorsSouth Carolina29687-
Texas Center For Drug Development, P.A.HoustonTexas77081-
Diabetes & Glandular Disease Research Associates, Inc.San AntonioTexas78229-
S.A.M. Clinical Research CenterSan AntonioTexas78229-
Optimum Clinical ResearchSalt Lake CityUtah84102-
Office Of Dr. GraySpokaneWashington99216-

Find similar trials in Tempe, AZ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Clinical Research Advantage / Desert Clinical Res, Llc· Tempe, AZMedical Group Of Encino· Encino, CAValley Research· Fresno, CARandall Shue, D.O.· Los Angeles, CADiabetes Medical Center Of California· Northridge, CARitchken & First M.D.'S· San Diego, CA

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