Study identifier:D1693C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study with a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg once daily in Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on a background combination of Metformin and Sulfonylurea
Type 2 Diabetes Mellitus
Phase 3
No
dapagliflozin, placebo
All
311
Interventional
18 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2015 by AstraZeneca
AstraZeneca
Bristol-Myers Squibb
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
Location
Location
Brampton, ON, Canada
Location
Edmonton, AB, Canada
Location
Quebec, QC, Canada
Location
Laval, QC, Canada
Location
Halifax, NS, Canada
Location
St. John's, NL, Canada
Location
Winnipeg, MB, Canada
Location
Kensington, PE, Canada
Arms | Assigned Interventions |
---|---|
Experimental: Dapagliflozin 10 mg tablet | Drug: dapagliflozin 10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period |
Placebo Comparator: matching placebo tablet | Drug: placebo matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period |
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