Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

Part of paid clinical trials in Fresno, California.

Sponsor
AstraZeneca
Study ID
NCT00673231
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
  • Dapagliflozin — DRUG
    Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
  • Dapagliflozin — DRUG
    Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
  • Placebo — DRUG
    Placebo
  • Dapagliflozin — DRUG
    tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
  • Dapagliflozin — DRUG
    tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg

Study Details

This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Key Dates

First listed
May 7, 2008
Start date
Apr 30, 2008
Status verified
Sep 2013
Primary completion
May 31, 2009
Completion
Jan 31, 2011

Study Design

Enrollment
1,240 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    2.5mg
  • Experimental: 2
    5mg
  • Experimental: 3
    10mg
  • Placebo Comparator: 4

Primary Outcome Measure

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

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteFresnoCalifornia--
Research SiteGreenbraeCalifornia--
Research SiteRoswellGeorgia--
Research SiteChicagoIllinois--
Research SiteSpringfieldIllinois--
Research SiteIndianapolisIndiana--
Research SiteOmahaNebraska--
Research SitePhiladelphiaPennsylvania--
Research SiteCorpus ChristiTexas--
Research SiteDallasTexas--
Research SiteNorfolkVirginia--
Research SiteRichmondVirginia--
Research SiteTacomaWashington--

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By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

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