Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

Sponsor
AstraZeneca
Study ID
NCT01392677
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • dapagliflozin — DRUG
    10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
  • placebo — DRUG
    matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Study Details

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Key Dates

Start date
Oct 31, 2011
Status verified
Feb 2014
Primary completion
Jan 31, 2013
Completion
Aug 31, 2013

Study Design

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

Arms

  • Experimental: Dapagliflozin 10 mg tablet
  • Placebo Comparator: matching placebo tablet

Primary Outcome Measure

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

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