Study identifier:D1691C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients with Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
Type 2 Diabetes
Phase 3
No
dapagliflozin, metformin, placebo
All
400
Interventional
18 Years - 77 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Oct 2014 by AstraZeneca
AstraZeneca
Bristol-Myers Squibb
This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.
Location
Location
ASSLAR, Germany
Location
BERLIN, Germany
Location
BIBERACH A.D. RISS, Germany
Location
BOSENHEIM, Germany
Location
DIPPOLDISWALDE, Germany
Location
FALKENSEE, Germany
Location
MEISSEN, Germany
Location
MUNCHEN, Germany
Arms | Assigned Interventions |
---|---|
Experimental: 1 Dapagliflozin 2.5 mg twice-daily plus open-label metformin | Drug: dapagliflozin 2.5 mg tablet, taken orally, twice daily Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily |
Experimental: 2 Dapagliflozin 5.0 mg twice-daily plus open-label metformin | Drug: dapagliflozin 5 mg tablet taken orally, twice daily Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily |
Experimental: 3 Dapagliflozin 10 mg once-daily plus open-label metformin | Drug: dapagliflozin 10 mg tablet taken orally, once daily Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily |
Placebo Comparator: 4 Placebo plus open-label metformin | Drug: metformin >/= 1500 mg total daily dose, tablets taken orally, twice daily Drug: placebo placebo |
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