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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
311
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Adjusted Mean Change From Baseline in HbA1c Levels
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
Time frame: Baseline to week 24
Adjusted Mean Change From Baseline in FPG
To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo
Time frame: Baseline to week 24
Adjusted Mean Change From Baseline in Total Body Weight
To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
Time frame: Baseline to week 24
Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, at week 24 (LOCF) between dapagliflozin and placebo
Time frame: Baseline to week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo
Time frame: Baseline to week 8
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Research Site
Edmonton, Alberta, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Sydney Mines, Nova Scotia, Canada
Research Site
Brampton, Ontario, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Markham, Ontario, Canada
Research Site
Smiths Falls, Ontario, Canada
Research Site
Kensington, Prince Edward Island, Canada
...and 32 more locations