Table 3.

Adjusted mean change from baseline in glycemic measures and body weight with dual add-on of saxagliptin (5 mg/day) and dapagliflozin (10 mg/day) to metformin

Efficacy end point	SAXA + DAPA + MET n = 179	SAXA + MET n = 176	DAPA + MET n = 179
HbA1c (%)
Baseline (mean ± SD)	8.93 ± 1.19	9.03 ± 1.05	8.87 ± 1.17
Mean change from baseline	−1.47 (−1.62, −1.31)	−0.88 (−1.03, −0.72)	−1.20 (−1.35, −1.04)
Difference vs saxagliptin + metformin	−0.59 (−0.81, −0.37) P < 0.0001
Difference vs dapagliflozin + metformin	−0.27 (−0.48, −0.05) P = 0.0166
PPG (mg/dL)
Baseline (mean ± SD)	243 ± 55.5	256 ± 64.3	247 ± 56.3
Mean change from baseline	−80 (−86.3, −72.8)	−36 (−42.5, −28.7)	−70 (−77.4, −63.5)
Difference vs saxagliptin + metformin	−44 (−53.7, −34.3) P<0.0001
Difference vs dapagliflozin + metformin	−9 (−18.8, 0.5) P=0.06
FPG (mg/dL)
Baseline (mean ± SD)	181 ± 45.5	192 ± 45.4	185 ± 47.6
Mean change from baseline	−38 (−43.2, −32.3)	−14 (−19.6, −8.4)	−32 (−37.3, −26.2)
Difference vs saxagliptin + metformin	−24 (−31.6, −15.9) NT
Difference vs dapagliflozin + metformin	−6 (−13.8, 1.7) NT
Patients with HbA1c <7%
x/n a	74/177	29/175	40/173
%	41 (34.5, 48.2)	18 (13.0, 23.5)	22 (16.1, 28.3)
Difference vs saxagliptin + metformin	23 (14.7, 31.5) NT
Difference vs dapagliflozin + metformin	19 (10.1, 28.1) NT
Body weight (kg)
Baseline (mean ± SD)	87.1 ± 18.0	88.0 ± 18.7	86.3 ± 18.6
Mean change from baseline	−2.1 (−2.5, −1.6)	0 (−0.5, 0.5)	−2.4 (−2.9, −1.9)
Difference vs saxagliptin + metformin	−2.1 (−2.7, −1.4) NT

Data are from NCT01606007 [30]. Values are mean (95% CI) unless otherwise indicated

Adapted with permission from Rosenstock et al. [30]

DAPA dapagliflozin, HbA1c glycated hemoglobin, FPG fasting plasma glucose, MET metformin, NT not tested under sequential testing procedure if previous tested end point was not statistically significant, PPG 2-h postprandial glucose, SAXA saxagliptin

^aNumber of responders/number of patients with baseline and week 24 values