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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01042977
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 improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's 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 and cardiovascular disease

Key Dates

Start date
Mar 31, 2010
Status verified
Dec 2013
Primary completion
May 31, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
964 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 (57)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama--
Research SiteScottsdaleArizona--
Research SiteAnaheimCalifornia--
Research SiteBell GardensCalifornia--
Research SiteChinoCalifornia--
Research SiteChula VistaCalifornia--
Research SiteHuntington BeachCalifornia--
Research SiteLos AngelesCalifornia--
Research SiteMission HillsCalifornia--
Research SiteRedondo BeachCalifornia--
Research SiteRiversideCalifornia--
Research SiteSacramentoCalifornia--
Research SiteSan DiegoCalifornia--
Research SiteTorranceCalifornia--
Research SiteAventuraFlorida--
Research SiteBoca RatonFlorida--
Research SiteBradentonFlorida--
Research SiteBrooksvilleFlorida--
Research SiteClearwaterFlorida--
Research SiteDania BeachFlorida--
Research SiteDelray BeachFlorida--
Research SiteNew Smyrna BeachFlorida--
Research SiteOrlandoFlorida--
Research SiteSpringfieldIllinois--
Research SiteAvonIndiana--
Research SiteFranklinIndiana--
Research SiteGreenfieldIndiana--
Research SiteMuncieIndiana--
Research SiteWaterlooIowa--
Research SiteTopekaKansas--
Research SitePaducahKentucky--
Research SiteAlexandriaLouisiana--
Research SiteRockvilleMaryland--
Research SiteKalamazooMichigan--
Research SiteLivoniaMichigan--
Research SiteBillingsMontana--
Research SiteBerlinNew Jersey--
Research SiteBrickNew Jersey--
Research SiteAsheboroNorth Carolina--
Research SiteFargoNorth Dakota--
Research SiteCincinnatiOhio--
Research SiteOklahoma CityOklahoma--
Research SiteAltoonaPennsylvania--
Research SiteEriePennsylvania--
Research SiteHollandPennsylvania--
Research SiteLancasterPennsylvania--
Research SiteMediaPennsylvania--
Research SitePhiladelphiaPennsylvania--
Research SiteAustinTexas--
Research SiteCorpus ChristiTexas--
Research SiteDallasTexas--
Research SiteIrvingTexas--
Research SiteRichardsonTexas--
Research SiteSan AntonioTexas--
Research SiteSugarlandTexas--
Research SiteAlexandriaVirginia--
Research SiteManassasVirginia--

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Birmingham, ALResearch Site· Scottsdale, AZResearch Site· Anaheim, CAResearch Site· Bell Gardens, CAResearch Site· Chino, CAResearch Site· Chula Vista, CA

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