Table 1

Demographics and baseline characteristics at randomization

Placebo add-on to saxagliptin plus metformin (n = 160)Dapagliflozin add-on to saxagliptin plus metformin (n = 160)Total (n = 320)
Age, years55.0 ± 9.655.2 ± 8.655.1 ± 9.1
Women84 (52.5)90 (56.3)174 (54.4)
Race
 White147 (91.9)150 (93.8)297 (92.8)
 African American10 (6.3)8 (5.0)18 (5.6)
 Asian1 (0.6)1 (0.6)2 (0.6)
 Other2 (1.3)1 (0.6)3 (0.9)
BMI, kg/m232.2 ± 5.331.2 ± 4.731.7 ± 5.1
Duration of diabetes, years8.0 ± 6.67.2 ± 5.77.6 ± 6.1
HbA1c
 %8.17 ± 0.988.24 ± 0.968.20 ± 0.97
 mmol/mol66 ± 10.767 ± 10.566 ± 10.6
HbA1c category
 <8% (64 mmol/mol)75 (46.9)69 (43.1)144 (45.0)
 ≥8% and <9% (≥64 and <75 mmol/mol)53 (33.1)51 (31.9)104 (32.5)
 ≥9% (75 mmol/mol)32 (20.0)40 (25.0)72 (22.5)
FPG, mg/dL177 ± 46.8179 ± 48.9178 ± 47.8
2-h PPG, mg/dL243 ± 57.5 (n = 154)242 ± 60.9 (n = 156)242 ± 59.1 (n = 310)
Fasting C-peptide, ng/mL2.6 ± 1.12.5 ± 1.12.6 ± 1.1
eGFR, mL/min/1.73 m291.6 ± 23.293.5 ± 20.892.5 ± 22.0
Randomization stratification
 Stratum A109 (68.1)110 (68.8)219 (68.4)
 Stratum B51 (31.9)50 (31.3)101 (31.6)
  • Data are mean ± SD or n (%), unless otherwise indicated. eGFR, estimated glomerular filtration rate calculated by MDRD formula.