Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension

Part of paid clinical trials in Gulf Shores, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01031680
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
  • Placebo — DRUG
    Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Study Details

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.

Key Dates

Start date
Feb 28, 2010
Status verified
Sep 2013
Primary completion
May 31, 2011
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: 1
    Dapagliflozin 10 mg tablet
  • Placebo Comparator: 2
    Matching placebo tablet

Primary Outcome Measure

Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ]

Locations (60)

FacilityCityStateZIPSite coordinators
Research SiteGulf ShoresAlabama--
Research SitePhoenixArizona--
Research SiteBurbankCalifornia--
Research SiteGarden GroveCalifornia--
Research SiteHuntington ParkCalifornia--
Research SiteLancasterCalifornia--
Research SiteSalinasCalifornia--
Research SiteSan MarinoCalifornia--
Research SiteSan RamonCalifornia--
Research SiteTustinCalifornia--
Research SiteColorado SpringsColorado--
Research SiteWaterburyConnecticut--
Research SiteClearwaterFlorida--
Research SiteDeerfield BeachFlorida--
Research SiteHialeahFlorida--
Research SiteHollywoodFlorida--
Research SiteJacksonvilleFlorida--
Research SiteMiamiFlorida--
Research SitePort CharlotteFlorida--
Research SitePort OrangeFlorida--
Research SiteTampaFlorida--
Research SiteWinter ParkFlorida--
Research SiteColumbusGeorgia--
Research SiteDecaturGeorgia--
Research SiteStone MountainGeorgia--
Research SiteHonoluluHawaii--
Research SiteChicagoIllinois--
Research SiteWichitaKansas--
Research SiteBaton RougeLouisiana--
Research SiteLake CharlesLouisiana--
Research SiteWest MonroeLouisiana--
Research SiteBaltimoreMaryland--
Research SiteKansas CityMissouri--
Research SiteSt LouisMissouri--
Research SiteLas VegasNevada--
Research SiteBrickNew Jersey--
Research SiteOradellNew Jersey--
Research SiteNew Hyde ParkNew York--
Research SiteThe BronxNew York--
Research SiteCincinnatiOhio--
Research SiteDaytonOhio--
Research SiteOklahoma CityOklahoma--
Research SitePhiladelphiaPennsylvania--
Research SitePhoenixvillePennsylvania--
Research SitePittsburghPennsylvania--
Research SiteReadingPennsylvania--
Research SiteCharlestonSouth Carolina--
Research SiteKingsportTennessee--
Research SiteCarrolltonTexas--
Research SiteDallasTexas--
Research SiteFort WorthTexas--
Research SiteHoustonTexas--
Research SiteNorth Richland HillsTexas--
Research SitePlanoTexas--
Research SiteSan AntonioTexas--
Research SiteTomballTexas--
Research SiteOgdenUtah--
Research SiteDanvilleVirginia--
Research SiteSpokaneWashington--
Research SiteTacomaWashington--

Find similar trials in Gulf Shores, AL

By condition
Hypertension (high blood pressure)Type 2 diabetes
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Research Site· Gulf Shores, ALResearch Site· Phoenix, AZResearch Site· Burbank, CAResearch Site· Garden Grove, CAResearch Site· Huntington Park, CAResearch Site· Lancaster, CA

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