This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
833
10 mg tablet, oral, once daily, 48 weeks
Matching placebo tablet
Adjusted Mean Change in HbA1c Levels
To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
Time frame: Baseline to Week 24
Adjusted Mean Change in Body Weight
To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.
Time frame: Baseline to Week 24
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.
Time frame: Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.
Time frame: Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP \>=130 achieved with dapagliflozin versus placebo from baseline to week 8.
Time frame: Baseline to Week 8
Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.
Time frame: Baseline to Week 24
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Research Site
Huntsville, Alabama, United States
Research Site
Ozark, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
Greenbrae, California, United States
Research Site
Laguna Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Riverside, California, United States
Research Site
West Hills, California, United States
Research Site
Boca Raton, Florida, United States
...and 78 more locations
Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline
To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
Time frame: Baseline to Week 24