Table 2

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

Placebo add-on to dapagliflozin plus metformin (n = 162)Saxagliptin add-on to dapagliflozin plus metformin (n = 153)P value
HbA1c
 Baseline mean ± SD, % (mmol/mol)7.85 ± 0.92 (62 ± 10.1)7.95 ± 0.83 (63 ± 9.1)
 Change from baseline, %−0.16 (–0.28 to –0.04)−0.51 (–0.63 to –0.39)
 Change from baseline, mmol/mol–1.7 (–3.1 to –0.4)–5.6 (–6.9 to –4.3)
 Difference in saxagliptin vs. placebo, % (mmol/mol)−0.35 (–0.52 to –0.18) (–3.8 [–5.7 to –2.0])<0.0001
2-h PPG, mg/dL
 Baseline mean ± SD204 ± 52.0208 ± 50.6
 Change from baseline−31 (–37.5 to –25.0)−37 (–43.6 to –30.7)
 Difference saxagliptin vs. placebo−6 (–14.9 to 3.1) 0.2014
FPG, mg/dL
 Baseline mean ± SD157 ± 33.94164 ± 34.3
 Change from baseline−5 (–10.4 to –0.2)−9 (–14.3 to –3.9)
 Difference saxagliptin vs. placebo−4 (–11.0 to –3.6) NT
Patients with HbA1c <7% (53 mmol/mol)
 x/n*39/16051/150
 Adjusted %23.1 (16.9 to 29.3)35.3 (28.2 to 42.4)
 Difference vs. saxagliptin + metformin, %12.2 (3.4 to 21.0) NT
  • Data are adjusted mean change from baseline (95% CI) or as indicated. NT, not tested because of hierarchical testing procedure.

  • *Number of responders/number of patients with nonmissing baseline values and week 24 values (last observation carried forward).