Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01646320
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
  • Placebo matching with Dapagliflozin — DRUG
    Tablets, Oral, 0 mg, Once daily, Up to 52 weeks
  • Saxagliptin — DRUG
    Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
  • Metformin immediate release (IR) — DRUG
    Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks

Study Details

The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

Key Dates

Start date
Sep 30, 2012
Status verified
May 2016
Primary completion
Aug 31, 2014
Completion
Feb 28, 2015

Study Design

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

Arms

  • Experimental: Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR
  • Experimental: Arm 2: Placebo + Saxagliptin + Metformin IR

Primary Outcome Measure

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

Locations (26)

FacilityCityStateZIPSite coordinators
University Of Alabama At BirminghamBirminghamAlabama35294-
Clinical Research Advantage Inc/Desert Clinical Research LlcMesaArizona85213-
Clinical Research Advantage, Inc.PhoenixArizona85018-
Elite Clinical Studies, LlcPhoenixArizona85018-
Arkansas Clinical ResearchLittle RockArkansas72205-
Torrance Clinical Research Institute Inc.LomitaCalifornia90717-
National Research InstituteLos AngelesCalifornia90057-
Randall G. Shue, Do, Inc.Los AngelesCalifornia90023-
Diabetes Medical Center Of CaliforniaNorthridgeCalifornia91325-
Cassidy Medical Group/Clinical Research AdvantageVistaCalifornia92083-
Palm Springs Research InstituteHialeahFlorida33012-
Fpa Clinical ResearchKissimmeeFlorida34741-
International Research Associates, LlcMiamiFlorida33183-
Omega Research Consultants, LlcOrlandoFlorida32804-
Compass Research East, LlcOviedoFlorida32765-
Palm Harbor Medical AssociatesPalm HarborFlorida34684-
Cedar Crosse Research CenterChicagoIllinois60607-
Clinical Research AdvantageEvansvilleIndiana47714-
Associated Internal Medicine SpecialistsBattle CreekMichigan49015-
Jackson ClinicRolling ForkMississippi39159-
Premier ResearchTrentonNew Jersey08611-
Metrolina Internal MedicineCharlotteNorth Carolina28204-
Sterling Research Grp, Ltd.CincinnatiOhio45246-
Endocrine AssociatesHoustonTexas77004-
Sam Clinical Research CenterSan AntonioTexas78229-
Tidewater Integrated Medical ResearchVirginia BeachVirginia23454-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University Of Alabama At Birmingham· Birmingham, ALClinical Research Advantage Inc/Desert Clinical Research Llc· Mesa, AZClinical Research Advantage, Inc.· Phoenix, AZElite Clinical Studies, Llc· Phoenix, AZArkansas Clinical Research· Little Rock, ARTorrance Clinical Research Institute Inc.· Lomita, CA

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