Evaluation of Dapagliflozin Taken Twice-daily

Sponsor
AstraZeneca
Study ID
NCT01217892
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • dapagliflozin — DRUG
    2.5 mg tablet, taken orally, twice daily
  • dapagliflozin — DRUG
    5 mg tablet taken orally, twice daily
  • dapagliflozin — DRUG
    10 mg tablet taken orally, once daily
  • metformin — DRUG
    \>/= 1500 mg total daily dose, tablets taken orally, twice daily
  • placebo — DRUG
    placebo

Study Details

This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.

Key Dates

Start date
Nov 30, 2010
Status verified
Oct 2014
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

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

Arms

  • Experimental: 1
    Dapagliflozin 2.5 mg twice-daily plus open-label metformin
  • Experimental: 2
    Dapagliflozin 5.0 mg twice-daily plus open-label metformin
  • Experimental: 3
    Dapagliflozin 10 mg once-daily plus open-label metformin
  • Placebo Comparator: 4
    Placebo plus open-label metformin

Primary Outcome Measure

Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 16 ]

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