Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

Sponsor
AstraZeneca
Study ID
NCT00855166
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Tablet oral 10 mg total daily dose once daily 102 weeks
  • Metformin — DRUG
    Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
  • Sitagliptin — DRUG
    Tablet oral 100 mg total daily dose once daily rescue medication
  • Placebo — DRUG
    Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Study Details

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Key Dates

Start date
Feb 28, 2009
Status verified
Aug 2013
Primary completion
Jun 30, 2010
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: A
    Dapagliflozin 10 mg plus Metformin
  • Placebo Comparator: B
    Placebo plus Metformin

Primary Outcome Measure

Adjusted Mean Change in Total Body Weight [ Time Frame: Baseline to Week 24 ]

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