Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients

Sponsor
AstraZeneca
Study ID
NCT00972244
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    once daily, 12 weeks
  • Placebo — DRUG
    once daily, 12 weeks

Study Details

The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.

Key Dates

Start date
Aug 31, 2009
Status verified
Aug 2013
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

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

Arms

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

Primary Outcome Measure

Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 12 ]

Related Studies