The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
477
Tablet
Tablet
Local Institution
Beijing, Beijing Municipality, China
Adjusted Mean Change in HbA1c From Baseline to Week 24
The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.
Time frame: Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).
Time frame: Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Body Weight From Baseline to Week 24
Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).
Time frame: Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24
The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).
Time frame: Baseline (Day 1) and 24 weeks
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