This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,217
Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Adjusted Mean Change in HbA1c Levels
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.
Time frame: Baseline to Week 52
Adjusted Mean Change in Body Weight
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.
Time frame: Baseline to Week 52
Proportion of Participants With at Least One Episode of Hypoglycemia
To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
Time frame: Baseline to Week 52
Proportion of Participants With Body Weight Reduction of at Least 5%
To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.
Time frame: Baseline to Week 52
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Research Site
Buenos Aires, Argentina
Research Site
Caba, Argentina
Research Site
Capital Federal, Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Corrientes, Argentina
Research Site
Córdoba, Argentina
Research Site
La Plata, Argentina
Research Site
Rosario, Argentina
Research Site
Santa Fe, Argentina
Research Site
L'Aigle, France
...and 66 more locations