Table 1

Clinical and immunological characteristics of the 20 enrolled patients at screening

No.SexBMI (kg/m2)Duration of disease (years)A1C (%)Basal (stim) C-peptide (ng/ml)Antibodies
HLA haplotypes
T-cell reactivity
ICA512GAD65DRB1DQB1Toronto (no. of + antigens)Seattle (no. of + sections)
1F24.310.27.60.70 (1.00)negpos0301, 16010201, 050240
2F27.122.06.20.75 (0.80)pospos0404, 0404*0302, 0302*9NR
3F21.06.38.40.75 (1.00)pospos0301, 04010201, 0302918
4M29.121.08.00.93 (1.10)negpos0301, 04010201, 03024NR
5F30.916.86.50.57 (0.80)posneg0401, 04020302, 0302*512
6M23.838.47.10.20 (0.50)negneg0301, 04050201, 03020NR
7F21.722.57.40.39 (0.60)negneg0301, 0301*0201, 0201*35
8M22.625.67.50.58 (0.89)negneg0405, 0405*0302, 0302*104
9F31.216.87.10.44 (0.62)negpos0301, 04050201, 0302105
10M24.75.95.90.63 (0.94)negpos0102, 15010501, 06026NR
11M24.624.07.90.15 (0.62)negneg0404, 11040302, 0301129
12M29.836.15.60.22 (0.36)negpos0301, 04010201, 030210NR
13M27.137.17.00.76 (1.10)negpos0301, 03010201, 0201110
14F30.04.17.00.60 (0.91)pospos0401, 13020301, 060411NR
15M27.412.46.81.20 (1.80)negpos0301, 16010201, 0502114
16F27.530.48.90.27 (0.42)negpos0401, 07010202, 030290
17F20.133.48.10.54 (0.68)negpos0301, 04010201, 0302NRNR
18M26.129.810.20.62 (0.72)negneg0301, 15010201, 0602NRNR
19F27.911.75.70.36 (0.56)pospos0408, 11040304, 0603NRNR
20F22.021.46.80.48 (0.68)pospos0101, 04010302, 0501NRNR
9M/11F25.9 ± 3.421.3 ± 10.77.3 ± 1.10.57 (0.81)6 of 2014 of 20See legendSee legend14 of 167 of 10
  • Patients 1–16 were randomized to one of four study arms and patients 1–14 completed the trial. Of the patients, 16 of 20 had high-susceptibility HLA haplotypes; 1 had a mixed and 1 a protective haplotype (indicated in bold print).

  • *Homozygosity is highly likely but could only be proven by family studies, which were not available;

  • †HLA type could not be differentiated with certainty (0301 vs. 0328); underlined numbers indicate that the haplotype belongs to one of five most susceptible subtypes (25). neg, negative; NR, no results available; pos, positive.