A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Sponsor
AstraZeneca
Study ID
NCT01095666
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, 1500-3000 mg, Twice daily, 24 weeks
  • Dapagliflozin Placebo — DRUG
    Tablets, Oral, 0 mg, Once daily, 24 weeks
  • Pioglitazone — DRUG
    Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Study Details

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

Key Dates

Start date
Jun 30, 2010
Status verified
Sep 2017
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
1,484 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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