Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

Part of paid clinical trials in Litchfield Park, Arizona.

Sponsor
AstraZeneca
Study ID
NCT00736879
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, Once Daily, Up to 24 weeks
  • Placebo — DRUG
    Tablets, Oral, Once Daily, Up to 24 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 diet and exercise alone. The safety of this treatment will also be studied

Key Dates

Start date
Sep 22, 2008
Status verified
Apr 2017
Primary completion
Dec 29, 2009
Completion
Dec 29, 2009

Study Design

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

Arms

  • Experimental: Dapagliflozin 1 mg
    Dapagliflozin: 1 mg
  • Experimental: Dapagliflozin 2.5 mg
    Dapagliflozin: 2.5 mg
  • Experimental: Dapagliflozin 5 mg
    Dapagliflozin: 5 mg
  • Placebo Comparator: Placebo
    Placebo: 0 mg

Primary Outcome Measure

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants [ Time Frame: Baseline (Day 1), Week 24 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Dedicated Clinical ResearchLitchfield ParkArizona85340-
43rd Medical Associates, P.C.PhoenixArizona85051-
Clinical Research Advantage, Inc.TempeArizona85282-
Valley ResearchFresnoCalifornia93720-
Marina Raikhel, Md, FaafpLomitaCalifornia90717-
Richard S. Cherlin, MdLos GatosCalifornia95032-
Orange County Research CenterTustinCalifornia92780-
Family Physicians Of GreeleyGreeleyColorado80634-
Coastal Connecticut Research, LlcNew LondonConnecticut06320-
Central Florida Clinical Trials, Inc.Altamonte SpringsFlorida32701-
Westside Center For Clinical ResearchJacksonvilleFlorida32205-
Panhandle Family Care AssociatesMariannaFlorida32446-
Endocrine Research Solutions, Inc.RoswellGeorgia30076-
Belzoni Clinical ResearchBelzoniMississippi39038-
R-ResearchHamiltonNew Jersey08690-
Internist Associates Of Central New YorkSyracuseNew York13210-
Southgate Medical GroupWest SenecaNew York14224-
Down East Medical Associates, PaMorehead CityNorth Carolina28557-
James J. Brown, MdAkronOhio44319-
Integris Family Care SouthOklahoma CityOklahoma73170-
Southeastern Research Associates, Inc.TaylorsSouth Carolina29687-
Abbott Clinical Research Group, IncSan AntonioTexas78224-
Avastra Clinical TrialsMidvaleUtah84047-
Optimum Clinical Research, Inc.Salt Lake CityUtah84102-
Capital Clinical Research CenterOlympiaWashington98502-
Stephen G. Danley, DoSpokaneWashington99216-

Find similar trials in Litchfield Park, AZ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Dedicated Clinical Research· Litchfield Park, AZ43rd Medical Associates, P.C.· Phoenix, AZClinical Research Advantage, Inc.· Tempe, AZValley Research· Fresno, CAMarina Raikhel, Md, Faafp· Lomita, CARichard S. Cherlin, Md· Los Gatos, CA

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