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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01619059
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this study is to learn if BMS-477118 (Saxagliptin) 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
Jun 30, 2012
Status verified
Mar 2016
Primary completion
Jun 30, 2014
Completion
Jan 31, 2015

Study Design

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

Arms

  • Experimental: Arm 1: Saxagliptin+Dapagliflozin+Metformin IR
  • Experimental: Arm 2: Placebo+Dapagliflozin+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 (34)

FacilityCityStateZIPSite coordinators
University Of Alabama At BirminghamBirminghamAlabama35294-
Terence T. Hart, MdMuscle ShoalsAlabama35662-
Clinical Research Advantage Inc/Desert Clinical Research LlcMesaArizona85213-
Mesa Family Medical CenterMesaArizona85203-
Clinical Research Advantage, IncPhoenixArizona85020-
Clinical Research Advantage, Inc./ Stonecreek Medical Associates, PcPhoenixArizona85028-
Beach Physicians Clinical Research Corp.Huntington BeachCalifornia92647-
Torrance Clinical ResearchLomitaCalifornia90717-
National Research InstituteLos AngelesCalifornia90057-
Randall G. Shue, Do, Inc.Los AngelesCalifornia90023-
Cassidy Medical Group/Clinical Research AdvantageVistaCalifornia92083-
Infosphere Clinical Research, Inc.West HillsCalifornia91307-
New West Physicians, PcGoldenColorado80401-
Southeast Clinical Research, LlcChieflandFlorida32626-
Clinical Therapeutics CorporationCoral GablesFlorida33134-
Medical Research Unlimited, LlcHialeahFlorida33012-
Care Partners Clinical Research, LlcJacksonvilleFlorida32277-
University Of Florida Endocrinology & DiabetesJacksonvilleFlorida32207-
Clinical Research Of Miami, Inc.MiamiFlorida33126-
Clinical Research AdvantageEvansvilleIndiana7714-
Clinical Research Advantage, Inc.EvansvilleIndiana47725-
Mercy Health ResearchSt LouisMissouri63141-
Clinical Research Advantage, Inc.Las VegasNevada89128-
Joslin Diabetes Center Affiliate Of SnhmcNashuaNew Hampshire03063-
N. Shore Diabetes & Endoc AssocNew Hyde ParkNew York11042-
Digiovanna Institute For Medical Education & ResearchNorth MassapequaNew York11758-
Barat Research Group, Inc.CharlotteNorth Carolina28262-
Sterling Research Grp, Ltd.CincinnatiOhio45219-
Physicians Research, Inc.ZanesvilleOhio43701-
Tlm Medical ServicesColumbiaSouth Carolina29204-
Family Medicine Of SayebrookMyrtle BeachSouth Carolina29588-
Holston Medical GroupBristolTennessee37620-
Vanderbilt Diabetes CenterNashvilleTennessee37232-
Padre Coast Clinical ResearchCorpus ChristiTexas78404-

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, ALTerence T. Hart, Md· Muscle Shoals, ALClinical Research Advantage Inc/Desert Clinical Research Llc· Mesa, AZMesa Family Medical Center· Mesa, AZClinical Research Advantage, Inc· Phoenix, AZClinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc· Phoenix, AZ

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