Table 1 Baseline characteristics of study participants
Placebo (n = 25) | Ustekinumab (n = 47) | |
|---|---|---|
Sex, n (%) | ||
Male | 16 (64) | 27 (57) |
Female | 9 (36) | 20 (43) |
Age of diagnosis in years, mean (s.d.) (min., max.) | 14.28 (1.65) (12, 18) | 13.83 (1.74) (11, 18) |
Age (categorical) (years), n (%) | ||
12–15 | 20 (80) | 39 (83) |
16–18 | 5 (20) | 8 (17) |
Age at screening in years, mean (s.d.) (min., max.) | 15.0 (1.63) (12.46, 18.77) | 14.49 (1.78) (12.18, 18.53) |
Peak C-peptide level at screening (nmol l−1), n (%) | ||
0.2–0.7 | 5 (20) | 8 (17) |
>0.7 | 20 (80) | 39 (83) |
Ethnicity, n (%) | ||
White | 20 (80) | 39 (83) |
Mixed race | 1 (4) | 4 (9) |
Black or Black British | 1 (4) | 2 (4) |
Asian or Asian British | 1 (4) | 1 (2) |
Other ethnicity | 2 (8) | 1 (2) |
Height (cm), mean (s.d.) (min., max.) | 167.7 (10.57) (147.8, 189.8) | 165.2 (10.21) (144.2, 184.0) |
Weight (kg), mean (s.d.) (min., max.) | 60.6 (13.70) (37.6, 96.6) | 57.7 (13.85) (31.0, 97.8) |
BMI (kg m−2), mean (s.d.) (min., max.) | 21.3 (3.39) (15.5, 28.4) | 21.0 (4.09) (14.9, 32.7) |
Number of positive β-cell autoantibodies | ||
1 | 4 | 4 |
2 | 4 | 17 |
3 | 17 | 26 |
zBMI, mean (s.d.) (min., max.) | 0.51 (0.97) (−1.58, 2.47) | 0.40 (1.19) (−1.84, 3.02) |
HbA1c, mean (s.d.) (min., max.) | 48.6 (13.25) (8a, 74) | 49.9 (10.15) (33, 80) |
Daily insulin dose (units kg−1), mean (s.d.) (min., max.) | 0.42 (0.19) (0.07, 0.80) | 0.49 (0.32) (0.04, 1.39) |
Duration of follow-up (months), mean (s.d.) (min., max.) | 12.78 (0.32) (11.86, 13.31) | 12.78 (0.98) (12.06, 18.16) |
C-peptide AUC at screening (nmol l−1 min−1), mean (s.d.) (min., max.) | 0.92 (0.48) (0.22, 1.87) | 0.89 (0.50) (0.17, 2.75) |
