Table 1

Baseline characteristics

CharacteristicPlacebo (n = 93)Sotagliflozin 200 mg (n = 89)Sotagliflozin 400 mg (n = 96)Total (N = 278)
inTandem1 participants, n (%)45 (48)44 (49)47 (49)136 (49)
inTandem2 participants, n (%)48 (52)45 (51)49 (51)142 (51)
Age (years)43.5 (14.2)44.2 (13.2)45.1 (12.1)44.3 (13.2)
Female sex, n (%)52 (55.9)47 (52.8)48 (50.0)147 (52.9)
Race or ethnic group, n (%)*
 White89 (95.7)86 (96.6)92 (95.8)267 (96.0)
 Black2 (2.2)02 (2.1)4 (1.4)
 Asian1 (1.1)001 (0.4)
 Other1 (1.1)3 (3.4)2 (2.1)6 (2.2)
 Hispanic/Latino ethnicity5 (5.4)4 (4.5)7 (7.3)16 (5.8)
HbA1c (%)7.6 (0.7)7.6 (0.6)7.6 (0.7)7.6 (0.7)
HbA1c (mmol/mol)59.5 (7.2)59.4 (7.0)59.1 (8.1)59.3 (7.4)
Diabetes duration (years)24.6 (12.8)22.2 (12.3)23.4 (12.0)23.4 (12.4)
Weight (kg)85.5 (17.9)86.4 (16.6)86.1 (16.9)86.0 (17.1)
BMI (kg/m2)29.4 (5.5)29.5 (4.8)29.7 (4.9)29.5 (5.0)
BMI ≥30 kg/m2, n (%)41 (44.1)41 (46.1)46 (47.9)128 (46.0)
Total daily insulin dose (IU/kg)0.8 (0.3)0.7 (0.2)0.8 (0.3)0.7 (0.3)
Daily insulin dose (IU/day)
 Total65.8 (34.6)60.3 (24.7)65.7 (33.0)64.0 (31.2)
 Basal34.6 (15.9)31.3 (14.0)33.8 (15.0)33.3 (15.0)
 Bolus and corrections31.2 (22.0)28.9 (15.3)31.9 (21.9)30.7 (20.0)
Insulin therapy, n (%)
 MDI44 (47.3)43 (48.3)48 (50.0)135 (48.6)
 CSII49 (52.7)46 (51.7)48 (50.0)143 (51.4)
  • Data are mean (SD) unless otherwise indicated.

  • *Determined according to patient self-report.