Add-on to metformin
A total of 546 patients with Type 2 diabetes with inadequate glycemic control (HbA1c [greater than or equal to] 7% and [less than or equal to] 10%) participated in a 24 weeks, placebo-controlled study to evaluate dapagliflozin in combination with metformin. (10,17) Patients on metformin at a dose of at least 1500 mg/day were randomized after completing a 2 weeks, single-blind, placebo lead-in period. Following the lead-in period, eligible patients were randomized to dapagliflozin 5 mg, dapagliflozin 10 mg, or placebo in addition to their current dose of metformin.
As add-on treatment to metformin, dapagliflozin 10 mg provided statistically significant improvements in HbA1c and FPG, and statistically significant reduction in body weight compared with placebo at week 24. Statistically significant (p < 0.05 for both doses) mean changes from baseline in systolic blood pressure relative to placebo plus metformin were -4.5 mmHg and -5.3 mmHg with dapagliflozin 5 mg and 10 mg plus metformin, respectively.
Active glipizide-controlled study add-on to metformin
Add-on to metforminA total of 546 patients with Type 2 diabetes with inadequate glycemic control (HbA1c [greater than or equal to] 7% and [less than or equal to] 10%) participated in a 24 weeks, placebo-controlled study to evaluate dapagliflozin in combination with metformin. (10,17) Patients on metformin at a dose of at least 1500 mg/day were randomized after completing a 2 weeks, single-blind, placebo lead-in period. Following the lead-in period, eligible patients were randomized to dapagliflozin 5 mg, dapagliflozin 10 mg, or placebo in addition to their current dose of metformin.As add-on treatment to metformin, dapagliflozin 10 mg provided statistically significant improvements in HbA1c and FPG, and statistically significant reduction in body weight compared with placebo at week 24. Statistically significant (p < 0.05 for both doses) mean changes from baseline in systolic blood pressure relative to placebo plus metformin were -4.5 mmHg and -5.3 mmHg with dapagliflozin 5 mg and 10 mg plus metformin, respectively.Active glipizide-controlled study add-on to metformin
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