Table 1

Demographic and baseline characteristics

Insulin plus placebo
(N = 13)Insulin plus dapagliflozin
1 mg
(N = 13)2.5 mg
(N = 15)5 mg
(N = 14)10 mg
(N = 15)
Age, years34.5 (12.2)33.7 (9.1)35.7 (13.9)34.8 (14.0)37.5 (15.2)
Sex, n (%)
 Male8 (61.5)5 (38.5)11 (73.3)8 (57.1)8 (53.3)
 Female5 (38.5)8 (61.5)4 (26.7)6 (42.9)7 (46.7)
Race, n (%)
 White11 (84.6)11 (84.6)14 (93.3)14 (100.0)12 (80.0)
 Black/African American1 (7.7)1 (7.7)1 (6.7)02 (13.3)
 Asian01 (7.7)000
 Other1 (7.7)0001 (6.7)
Weight, kg78.0 (11.4)77.0 (16.7)77.4 (13.4)67.3 (7.6)78.4 (19.9)
BMI, kg/m225.3 (3.0)25.1 (3.8)24.8 (2.7)23.4 (2.4)25.8 (4.8)
BMI category, n (%)
 ≤23 kg/m24 (30.8)4 (30.8)5 (33.3)6 (42.9)6 (40.0)
 >23 kg/m29 (69.2)9 (69.2)10 (66.7)8 (57.1)9 (60.0)
Insulin method, n (%)
 Insulin pump6 (46.2)6 (46.2)7 (46.7)7 (50.0)7 (46.7)
 Daily injections7 (53.8)7 (53.8)8 (53.3)7 (50.0)8 (53.3)
Duration of T1D, years16.2 (9.7)20.1 (9.6)21.7 (12.3)17.2 (10.6)18.1 (14.0)
HbA1c, %8.75 (0.92)8.21 (0.68)8.45 (0.86)8.50 (0.78)8.39 (0.82)
HbA1c, mmol/mol72 (10.1)66 (7.4)69 (9.4)69 (8.5)68 (9.0)
FPG, mmol/L8.82 (4.29)8.13 (4.05)8.71 (3.51)8.78 (3.26)8.57 (4.18)
Urinary glucose excretion, g/24 h30.4 (51.6)6.6 (6.5)*12.1 (12.2)11.1 (10.8)11.9 (14.1)*
Seated systolic BP, mmHg113.3 (11.2)109.6 (9.5)114.4 (10.5)113.6 (10.9)115.9 (14.2)
eGFR (MDRD formula), n (%)
 <60 mL/min/1.73 m20001 (7.1)0
 ≥60 and <90 mL/min/1.73 m25 (38.5)6 (46.2)11 (73.3)7 (50.0)4 (26.7)
 ≥90 mL/min/1.73 m28 (61.5)7 (53.8)4 (26.7)6 (42.9)11 (73.3)
  • Data are reported as the mean (SD), unless otherwise stated.

  • N is the number of randomized patients who took at least one dose of double-blind study medication.

  • BP, blood pressure; eGFR, estimated glomerular filtration rate; MDRD, modification of diet in renal disease.

  • * Baseline data missing in one patient.