Table 2

Adjusted mean change from baseline at 24 weeks for primary and secondary efficacy end points

Placebo add-on to saxagliptin plus metformin (n = 160)Dapagliflozin add-on to saxagliptin plus metformin (n = 160)
HbA1c
 Baseline, mean ± SD, % [mmol/mol]8.16 ± 0.99 [66 ± 10.8]8.24 ± 0.97 [67 ± 10.6]
 Change from baseline, % [mmol/mol]−0.10 (−0.24, 0.04)
[−1.1 (−2.6, 0.4)]
−0.82 (−0.96, −0.69)
[−9 (−10.5, −7.5)]
 Difference dapagliflozin vs. placebo, % [mmol/mol]−0.72 (−0.91, −0.53)
[−7.9 (−9.9, −5.8)]
P < 0.0001
FPG, mg/dL
 Baseline, mean ± SD177 ± 46.8179 ± 48.7
 Change from baseline−5 (−11.1, 0.60)−33 (−38.3, −27.2)
 Difference dapagliflozin vs. placebo−28 (−35.4, −19.6)
P < 0.0001
2-h PPG, mg/dL
 Baseline, mean ± SD241 ± 57.1240 ± 60.9
 Change from baseline−38 (−46.1, −29.9)−74 (−81.5, −65.5)
 Difference dapagliflozin vs. placebo−36 (−46.3, −24.7)
P < 0.0001
Body weight, kg
 Baseline, mean ± SD88.2 ± 18.185.8 ± 18.4
 Change from baseline−0.4 (−0.86, 0.04)−1.9 (−2.34, −1.48)
 Difference dapagliflozin vs. placebo−1.5 (−2.12, −0.89)
P < 0.0001
Patients with HbA1c <7% (53 mmol/mol)
x/n21/15858/158
 Adjusted %12.4 (7.0, 17.9)38.0 (30.9, 45.1)
 Difference vs. saxagliptin plus metformin, %25.5 (16.7, 34.4)
P < 0.0001
  • Data are adjusted mean change from baseline (95% CI), unless otherwise indicated. PPG, postprandial plasma glucose; x/n, number of responders/number of patients with nonmissing baseline and week 24 values; LOCF, last observation carried forward.