Table 2

Changes from baseline at week 24 in efficacy parameters, vital signs, and laboratory values

PlaceboPrimary cohortExploratory cohorts
Dapagliflozin morning doseDapagliflozin evening doseDapagliflozin morning dose (A1C ≥10.1)
2.5 mg5 mg10 mg2.5 mg5 mg10 mg5 mg10 mg
n756564706768763439
A1C (%)*−0.23 ± 0.10−0.58 ± 0.11−0.77 ± 0.11−0.89 ± 0.11#−0.83 ± 0.11−0.79 ± 0.11−0.79 ± 0.10−2.88 ± 1.41−2.66 ± 1.26
FPG (mg/dl)*−4.1 ± 3.9−15.2 ± 4.2−24.1 ± 4.3−28.8 ± 4.0#−25.6 ± 4.1−27.3 ± 4.2−29.6 ± 4.0−77.1 ± 53.4−84.3 ± 61.0
Weight (kg)*−2.2 ± 0.4−3.3 ± 0.5−2.8 ± 0.5−3.2 ± 0.5−3.8 ± 0.5−3.6 ± 0.5−3.1 ± 0.4−2.1 ± 3.4−1.9 ± 3.5
Urinary glucose: creatinine (g/g)§0.96 ± 2.8712.12 ± 2.9817.68 ± 3.2833.80 ± 3.0824.24 ± 3.0738.00 ± 3.0945.80 ± 2.86NANA
Vital signs
    Seated systolic blood pressure (mmHg)§−0.9 ± 1.8−4.6 ± 1.8−2.3 ± 1.9−3.6 ± 1.9−4.0 ± 2.3−5.2 ± 1.7−2.3 ± 1.4−5.7 ± 2.1−2.5 ± 2.1
    Seated diastolic blood pressure (mmHg)§−0.7 ± 1.0−2.8 ± 1.1−1.7 ± 1.1−2.0 ± 1.1−3.2 ± 1.2−2.0 ± 1.1−1.0 ± 1.0−3.3 ± 1.6−2.9 ± 1.5
Laboratory values
    Serum creatinine (μmol/l)§−0.4 ± 0.9−0.6 ± 1.3−2.0 ± 1.4−1.1 ± 1.0−0.5 ± 0.91.8 ± 0.9−1.9 ± 1.70.0 ± 1.20.6 ± 1.4
    Serum albumin (g/l)§−0.1 ± 0.30.6 ± 0.40.3 ± 0.40.9 ± 0.30.0 ± 0.31.0 ± 0.41.3 ± 0.30.4 ± 0.50.7 ± 0.4
    Cystatin C (mg/l)§−0.014 ± 0.012−0.009 ± 0.0140.005 ± 0.014−0.003 ± 0.0160.014 ± 0.0120.024 ± 0.009−0.015 ± 0.0260.070 ± 0.025−0.045 ± 0.063
    Hematocrit (%)§−0.38 ± 0.251.60 ± 0.331.74 ± 0.402.38 ± 0.441.23 ± 0.261.92 ± 0.302.41 ± 0.300.77 ± 0.571.88 ± 0.42
    Serum uric acid (μmol/l)§−11.9 ± 5.6−39.3 ± 6.0−50.6 ± 6.1−51.7 ± 5.8−59.5 ± 5.9−43.4 ± 6.0−49.4 ± 5.6NANA
    Blood urea nitrogen (mmol/l)§0.2 ± 0.20.6 ± 0.20.6 ± 0.20.4 ± 0.20.6 ± 0.20.7 ± 0.20.4 ± 0.20.6 ± 0.20.9 ± 0.3
Serum electrolytes§
    Sodium (mmol/l)−0.1 ± 0.3−0.1 ± 0.3−0.9 ± 0.4−0.4 ± 0.4−0.1 ± 0.3−0.2 ± 0.30.1 ± 0.31.7 ± 0.60.5 ± 0.5
    Potassium (mmol/l)−0.03 ± 0.06−0.05 ± 0.050 ± 0.05−0.01 ± 0.06−0.03 ± 0.06−0.09 ± 0.05−0.08 ± 0.06−0.05 ± 0.08−0.02 ± 0.06
    Calcium (mmol/l)0.01 ± 0.010.03 ± 0.020.00 ± 0.020.03 ± 0.010.01 ± 0.010.04 ± 0.020.04 ± 0.02NANA
    Magnesium (mmol/l)−0.25 ± 0.180 ± 0.200.50 ± 0.260 ± 0.260 ± 0.250.15 ± 0.22−0.20 ± 0.27NANA
    Inorganic phosphorus (mmol/l)−0.01 ± 0.020.01 ± 0.020.04 ± 0.030.05 ± 0.020.04 ± 0.020.08 ± 0.020.06 ± 0.020.04 ± 0.030.07 ± 0.02
  • Data are means ± SEM unless otherwise indicated. NA, not assessed.

  • *Assessed in patients without missing baseline and week 24 values with last observation carried forward.

  • †Mean value after adjustment for baseline value.

  • ‡Data are means ± SD.

  • §Assessed in patients without missing baseline and week 24 values.

  • ‖Ratio from morning fasting spot urine test.

  • P < 0.001;

  • #P < 0.0001 (α = 0.019 [two-sided] applying Dunnett adjustment; secondary end points were tested using a sequential procedure).