Study identifier:D1690C00019
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A 24-week, multicentre, randomised, double-blind,age-stratified, placebo controlled phase III study with an 80-week extension period to evaluate the efficacy and safety of dapagliflozin 10 mg once daily in patients with T2DM and cardiovascular disease, who exhibit inadequate glycaemic control on usual care
Type 2 Diabetes Mellitus
Phase 3
No
Dapagliflozin, Placebo
All
964
Interventional
45 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2013 by AstraZeneca
AstraZeneca
Bristol-Myers Squibb
This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease
Location
Location
BUENOS AIRES, CABA, Argentina
Location
CORDOBA, Cordoba, Argentina
Location
ROSARIO, SANTA FE, Argentina
Location
SALTA, Salta, Argentina
Location
SANTA FE, SANTA FE, Argentina
Location
ADELAIDE, SA, Australia
Location
BEDFORD PARK, SA, Australia
Location
BLACKTOWN, NSW, Australia
Arms | Assigned Interventions |
---|---|
Experimental: 1 dapagliflozin 10 mg tablet | Drug: Dapagliflozin 10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period |
Placebo Comparator: 2 matching placebo tablet | Drug: Placebo matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period |
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