The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
321
Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
Time frame: Baseline, Week 24
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Time frame: Baseline, Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" represents the number with change from baseline available at Week 24.
Time frame: Baseline, Week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" represents the number with change from baseline available at Week 24.
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Research Site
Huntsville, Alabama, United States
Research Site
Burbank, California, United States
Research Site
Chula Vista, California, United States
Research Site
Concord, California, United States
Research Site
Fullerton, California, United States
Research Site
Huntington Beach, California, United States
Research Site
Los Gatos, California, United States
Research Site
Newport Beach, California, United States
Research Site
Salinas, California, United States
Research Site
Miami, Florida, United States
...and 77 more locations
Time frame: Baseline, Week 24