Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Sponsor
AstraZeneca
Study ID
NCT00660907
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • dapagliflozin — DRUG
    Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
  • glipizide — DRUG
    Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
  • metformin hydrochloride — DRUG
    Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks

Study Details

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Key Dates

Start date
Mar 31, 2008
Status verified
Mar 2015
Primary completion
Dec 31, 2009
Completion
Jan 31, 2013

Study Design

Enrollment
1,217 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    dapagliflozin plus metformin
  • Active Comparator: 2
    glipizide plus metformin

Primary Outcome Measure

Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 52 ]

Related Studies