Table 1

Demographic and baseline characteristics

CharacteristicDapagliflozin 5 mg + insulin (n = 271)Dapagliflozin 10 mg + insulin (n = 270)Placebo + insulin (n = 272)
Sex
 Male118 (43.5%)121 (44.8%)119 (43.8%)
 Female153 (56.5%)149 (55.2%)153 (56.3%)
Age (years)42.7 (13.35)42.4 (12.80)43.0 (13.73)
Body weight (kg)78.74 (17.38)80.06 (18.30)78.88 (18.87)
BMI (kg/m2)27.27 (5.13)27.80 (5.53)27.62 (5.41)
Race
 White210 (77.5%)219 (81.1%)208 (76.5%)
 Black or African American4 (1.5%)7 (2.6%)1 (0.4%)
 Asian57 (21.0%)44 (16.3%)59 (21.7%)
 Other004 (1.5)
Geographic region
 North America96 (35.4%)96 (35.6%)89 (32.7%)
 Latin America41 (15.1%)32 (11.9%)33 (12.1%)
 Europe79 (29.2%)101 (37.4%)92 (33.8%)
 Asia-Pacific55 (20.3%)41 (15.2%)58 (21.3%)
Duration of T1D (years)19.35 (11.79)19.45 (11.90)18.98 (11.65)
Total baseline insulin dose
 Dose (IU)58.19 (27.93)58.68 (28.26)56.57 (25.23)
 Dose/weight (IU/kg)0.73 (0.26)0.73 (0.27)0.71 (0.24)
Method of insulin administration
 MDI179 (66.1%)178 (65.9%)180 (66.2%)
 CSII92 (33.9%)92 (34.1%)92 (33.8%)
 Use of CGM (Yes)88 (32.5%)85 (31.5%)85 (31.3%)
 HbA1c (%)8.45 (0.69)8.43 (0.69)8.43 (0.65)
 HbA1c (mmol/mol)69 (7.5)69 (7.5)69 (7.1)
HbA1c at randomization
 ≥7.5% and <9.0%211 (77.9%)210 (77.8%)211 (77.6%)
 ≥9.0% and ≤10.5%60 (22.1%)60 (22.2%)61 (22.4%)
  • Data are n (%) or mean (SD). T1D, type 1 diabetes.