Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

Part of paid clinical trials in Mesa, Arizona.

Sponsor
AstraZeneca
Study ID
NCT00663260
Phase
PHASE2/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, 104 weeks
  • Dapagliflozin — DRUG
    Tablets, Oral, 5 mg, Once Daily, 104 weeks
  • Placebo — DRUG
    Tablets, Oral, 0 mg, Once Daily, 104 weeks

Study Details

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Key Dates

Start date
Jun 30, 2008
Status verified
Dec 2016
Primary completion
Dec 31, 2009
Completion
Jun 30, 2011

Study Design

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

Arms

  • Active Comparator: Dapagliflozin (10 mg)
  • Active Comparator: Dapagliflozin (5 mg)
  • Placebo Comparator: Placebo

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 (34)

FacilityCityStateZIPSite coordinators
Vista Medical Research, Inc.MesaArizona85206-
Valley ResearchFresnoCalifornia93720-
Marin Endocrine Care & Research, Inc.GreenbraeCalifornia94904-
Office Of Richard Cherlin, MdLos GatosCalifornia95032-
Diabetes Medical Center Of CaliforniaNorthridgeCalifornia91325-
Apex Research Of RiversideRiversideCalifornia92505-
La Biomed At Harbor Ucla Med Ctr.TorranceCalifornia90502-
Endocrine Associates Of The RockiesDenverColorado80220-
Panhandle Family Care AssociatesMariannaFlorida32446-
Genesis Clinical ResearchTampaFlorida33614-
Endocrine Research Solutions, Inc.RoswellGeorgia30076-
Twin Cities Clinical ResearchBrooklyn CenterMinnesota55430-
Kcva Medical Center Research Svc (151)Kansas CityMissouri64128-
Va Nebraska-Western Iowa Health Care System (Nwihcs)OmahaNebraska68105-
University Of Medicine And Dentistry Of New JerseyVoorhees TownshipNew Jersey08043-
Winthrop University HospitalMineolaNew York11501-
Slocum-Dickson Medical Group, PllcNew HartfordNew York13413-
Community Health Care Of ManchesterAkronOhio44319-
Center For Thyroid Diseases And EndocrinologyBeachwoodOhio44122-
Physician Research, Inc.ZanesvilleOhio43701-
Univ Of Oklahoma Health Science CenterOklahoma CityOklahoma73104-
Rogue Valley Clinical ResearchMedfordOregon97504-
Drexel University College Of MedicinePhiladelphiaPennsylvania19102-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Low Country Internal Medicine Of Sc, PaCharlestonSouth Carolina29406-
Carolina Health SpecialistsMyrtle BeachSouth Carolina29572-
Palmetto Clinical ResearchSummervilleSouth Carolina29485-
Research Institute Of DallasDallasTexas75231-
Westbury Medical Clinic P.A.HoustonTexas77005-
The Strelitz Diabetes CenterNorfolkVirginia23510-
Capital Clinical Research CenterOlympiaWashington98502-
Cedar Research LlcTacomaWashington98405-
Aurora Advanced HealthcareMilwaukeeWisconsin53209-
Zablocki Veterans Affairs Medical CenterMilwaukeeWisconsin53295-

Find similar trials in Mesa, AZ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Vista Medical Research, Inc.· Mesa, AZValley Research· Fresno, CAMarin Endocrine Care & Research, Inc.· Greenbrae, CAOffice Of Richard Cherlin, Md· Los Gatos, CADiabetes Medical Center Of California· Northridge, CAApex Research Of Riverside· Riverside, CA

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