Table 1

Demographic and baseline characteristics of randomly assigned patients in the treatment cohort

Placebo + insulin10 mg dapagliflozin + insulin20 mg dapagliflozin + insulin
n232424
Age (years)58.4 ± 6.555.7 ± 9.256.1 ± 10.6
Sex
    Male16 (69.6)13 (54.2)13 (54.2)
    Female7 (30.4)11 (45.8)11 (45.8)
Race
    White22 (95.7)22 (91.7)23 (95.8)
    Black/African American01 (4.2)1 (4.2)
    Asian01 (4.2)0
    Other1 (4.3)00
Ethnicity*
    Hispanic/Latino5 (21.7)3 (12.5)2 (8.3)
    Non-Hispanic/Latino12 (52.2)14 (58.3)16 (66.7)
    Not reported6 (26.1)7 (29.2)6 (25.0)
Weight (kg)101.8 ± 16.5103.4 ± 10.2101.2 ± 15.3
BMI (kg/m2)34.8 ± 4.635.5 ± 3.636.2 ± 4.6
Duration of type 2 diabetes (years)13.8 ± 7.311.8 ± 5.811.3 ± 5.6
Background antihyperglycemic medication
    Metformin + insulin18 (78.3)19 (79.2)16 (66.7)
    Metformin + insulin + TZD4 (17.4)2 (8.3)6 (25.0)
    TZD + insulin1 (4.3)3 (12.5)2 (8.3)
Total daily insulin dose90.0 (70.0–136.0)93.0 (67.5–136.0)84.5 (58.0–135.5)
A1C (%)8.4 ± 0.98.4 ± 0.78.5 ± 0.9
FPG (mg/dl)165.9 ± 51.5156.0 ± 39.0161.6 ± 55.0
  • Data are means ± SD, n (%), or median (interquartile range).

  • *Ethnicity data were collected for sites in the U.S. only.

  • †Before 50% insulin dose reduction on day 1 of double-blind period.