A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Sponsor
AstraZeneca
Study ID
NCT01095653
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 5 mg, Once daily, 24 weeks
  • Dapagliflozin — DRUG
    Tablets, Oral, 10 mg, Once daily, 24 weeks
  • Metformin — DRUG
    Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
  • Dapagliflozin Placebo — DRUG
    Tablets, Oral, 0 mg, Once daily, 24 weeks

Study Details

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

Key Dates

Start date
Jun 30, 2010
Status verified
Dec 2016
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
1,179 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
  • Experimental: Group 2
  • Experimental: Group 3

Primary Outcome Measure

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]

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