Table 1.
Characteristics of patients upon randomization.
| Variable | Placebo (n = 20) |
AAT-60 mg/kg (n = 26) |
AAT-120 mg/kg (n = 23) |
|---|---|---|---|
| Male sex | 12 (60.0) | 12 (46.1) | 13 (56.5) |
| Age (years) | 14 (4.8) | 12.8 (3.3) | 12.7 (4.3) |
| Children (8–11 years) | 7 (5.0) | 8 (30.8) | 12 (52.2) |
| Adolescents (12–18 years) | 9 (45.0) | 17 (65.4) | 9 (39.1) |
| Young adults (19–25 years) | 4 (20.0) | 1 (3.8) | 2 (8.7) |
| BMI (kg/m2) | 19.5 (3.8) | 19.2 (2.8) | 19.3 (4.0) |
| BMI-SDS (8–19 years) | 0.10 (1.39) | 0.22 (0.91) | 0.22 (1.15) |
| Time since diagnosis (days) | 67.1 (23.7) | 71.7 (26.2) | 75.1 (28.6) |
| Diabetic ketoacidosis at diagnosis | 11 (55.0) | 9 (34.6) | 11 (47.8) |
| HbA1c (%) | 8.5 (1.5) | 8.5 (2.2) | 8.7 (1.8) |
| HbA1c (mmol/mol) | 69 (16) | 69 (23) | 72 (19) |
| C-peptide, fasting (pmol/mL) | 0.24 (0.14) | 0.20 (0.11) | 0.22 (0.13) |
| C-peptide, stimulated (pmol/mL) | 0.68 (0.39) | 0.63 (0.35) | 0.59 (0.34) |
| Glutamic acid decarboxylase autoantibodies | 19 (95) | 24 (92) | 22 (96) |
| Islet-cell autoantibodies | 9 (45) | 15 (58) | 12 (52) |
| Positive for two autoantibodies | 8 (40) | 14 (54) | 11 (48) |
Note: data are mean (SD), n (%).