A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- AstraZeneca
- Study ID
- NCT00528372
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 77 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin — DRUGTablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
- Dapagliflozin placebo — DRUGTablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks
- Metformin — DRUG
Study Details
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this treatment will also be studied.
Key Dates
- Start date
- Sep 30, 2007
- Status verified
- Sep 2015
- Primary completion
- Feb 28, 2009
- Completion
- Jul 31, 2010
Study Design
- Enrollment
- 1,067 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1: Dapagliflozin, 2.5 mg AMParticipants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.
- Experimental: Group 1: Dapagliflozin, 10 mg AMParticipants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.
- Experimental: Group 1: Dapagliflozin 2.5 mg PMParticipants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.
- Experimental: Group 1: Dapagliflozin, 5 mg PMParticipants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks.
- Experimental: Group 1: Dapagliflozin, 10 mg PMParticipants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks.
- Experimental: Group 2: Dapagliflozin, 5 mg AMParticipants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.
- Experimental: Group 2: Dapagliflozin, 10 mg AMParticipants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.
- Experimental: Group 1: Dapagliflozin placebo AM & PMParticipants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.
- Experimental: Group 1: Dapaglifozon, 5 mg AMParticipants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.
Primary Outcome Measure
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1 [ Time Frame: Baseline to Week 24 (end of Short-term Period) ]
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