Table 1.
Baseline Characteristics of Subjects at Entry
| Al×3 N=48 |
GAD/Al×2 + Al N=49 |
GAD/Al×3 N=48 |
|
|---|---|---|---|
| Age- yr Mean Median Range |
16.6 ± 9.23 14.5 4 - 45 |
14.9 ± 8.72 14 3 - 45 |
17.9 ± 10.4 15.5 3 - 44 |
| Female sex- no. of patients (%) | 19 (39.6) | 31 (63.3) | 14 (29.2) |
| Race - no. of patients* (%) White |
40 (85.1) | 45 (93.8) | 43 (91.5) |
| Ethnicity - no. of patients (%) Non-Hispanic |
48 (100.0) | 49 (100.0) | 48 (100.0) |
| No. of autoantibodies** - no. of patients (%) 1 2 3 4 |
1 (2.1) 10 (20.8) 24 (50.0) 13 (27.1) |
0 (0.0) 10 (20.4) 23 (46.9) 16 (32.7) |
3 (6.2) 10 (20.8) 14 (29.2) 21 (43.8) |
| GAD Antibody Titre (index units) | 0.336 ± 0.307 | 0.349 ± 0.381 | 0.230 ± 0.224 |
| No. of days from diagnosis to first infusion | 87.1 ± 15.5 | 87.0 ± 14.1 | 83.9 ± 16.8 |
| Range | 42 - 106 | 47 - 104 | 45 - 105 |
| Weight (kg) | 56.4 ± 21.3 | 48.7 ± 18.4 | 61.4 ± 22.9 |
| Body Mass Index (kg/m2) | 20.9 ± 4.22 | 20.0 ± 3.66 | 22.3 ± 4.69 |
| AUC Mean for C-peptide (pmol/ml) | 0.690 ± 0.278 | 0.655 ± 0.374 | 0.710 ± 0.362 |
| Glycated hemoglobin at baseline (HbA1c -%) | 6.39 ± 0.844 | 6.63 ± 0.965 | 6.63 ± 1.19 |
| Total daily insulin dose at baseline* – (U/kg) | 0.395 ± 0.251 | 0.331 ± 0.219 | 0.386 ± 0.229 |
| Ketoacidosis at diagnosis - no. of patients (%) | 6 (13.3) | 11(25.0) | 9 (21.4) |
| Diabetes associated HLA alleles present - no. of patients* (%) DR3 and DR4 DR3 only DR4 only Neither |
14 (29.8) 8 (17.0) 20 (42.6) 5 (10.6) |
7 (14.3) 13 (26.5) 21 (42.9) 8 ( 16.3) |
13 (27.1) 15 (31.2) 13 (27.1) 7 ( 14.6) |
Unless otherwise indicated statistics displayed are means with standard deviations.
*
Descriptive statistics excludes some subjects (3 – race not reported, 3 - did not provide baseline insulin use, 1 – HLA allele test not done)
**
ICA not tested on 3 subjects, (considered negative for count)