Table 1

Baseline characteristics of the treatment groups, including all 114 subjects correctly randomized

MMF + DZBMMF alone
ActiveControlActiveControl
n41423128
Age (years)18.3 ± 9.118.8 ± 10.517.1 ± 6.715.8 ± 8.0
Race (% white)38 (93)39 (93)30 (97)27 (96)
    Non-Hispanic (%)40 (98)39 (93)29 (94)26 (93)
Number of Ab+ (%)
    11 (2)3 (7)4 (13)1 (4)
    211 (27)8 (19)7 (23)7 (25)
    312 (29)16 (38)6 (19)11 (39)
    417 (41)15 (36)14 (45)9 (32)
Male sex (%)23 (56)25 (60)20 (65)16 (57)
2-h C-peptide AUC means (pmol/ml)0.71 ± 0.360.71 ± 0.340.65 ± 0.280.73 ± 0.36
Baseline A1C (%)7.5 ± 1.37.7 ± 1.67.4 ± 1.07.5 ± 1.5
Baseline total insulin dose/kg0.40 ± 0.260.36 ± 0.200.35 ± 0.150.39 ± 0.22
Weight (kg)58.9 ± 16.659.0 ± 16.361.3 ± 18.357.2 ± 16.7
Height (cm)162.4 ± 13.5162.7 ± 13.7164.4 ± 15.4160.9 ± 13.4
BMI (kg/m2)22.0 ± 4.221.8 ± 3.622.1 ± 4.121.6 ± 4.0
zBMI (only on subjects <20 years)0.44 ± 1.110.66 ± 0.790.42 ± 1.020.57 ± 0.74
    n30282123
Mean A1C over 24 months (%)7.2 ± 1.27.2 ± 1.07.0 ± 1.27.3 ± 0.9
Mean insulin dose/kg over 24 months0.56 ± 0.290.55 ± 0.320.59 ± 0.310.63 ± 0.34
Mean MPA level over 24 months (mcg/ml)*4.5 ± 3.40.6 ± 0.65.8 ± 4.00.6 ± 0.2
Received 2 full DZB infusions (%)40 (98)**42 (100)31 (100)28 (100)
% of subjects MMF compliant***36 (88)41 (98)27 (87)27 (96)
  • Means ± SD are presented for continuous variables.

  • *Limit of quantitation = 0.5 units.

  • **One subject did not receive the second infusion due to patient decision to continue study treatment.

  • ***80% or greater by capsule count up through last recorded visit starting with month 3.