Table 1.
Patient characteristics
| Characteristic | All participants
|
Stratum 1 (4–8 months) (n=39)
|
Stratum 2 (9–12 months) (n=19)
|
|||
|---|---|---|---|---|---|---|
| Drug (n=31) | Placebo (n=27) | Drug (n=21) | Placebo (n=18) | Drug (n=10) | Placebo (n=9) | |
| Age (years)(±SD) | 12.9±4.18 | 12.0±5.2 | 12.4±3.76 | 10.9±4.24 | 13.4±5.09 | 14.0±5.43 |
| Age category (n) | ||||||
| < 15 yrs | 18 | 20 | 13 | 15 | 5 | 5 |
| ≥ 15 yrs | 13 | 7 | 8 | 3 | 5 | 4 |
| Sex (% male) | 52 | 63 | 62 | 56 | 40 | 44% |
| Baseline C-peptide AUC (nmol/l) (±SD) | 0.618±0.302 | 0.6±0.43 | 0.611±0.289 | 0.557±0.464 | 0.632±0.342 | 0.686±0.365 |
| Baseline insulin use (U kg−1 day−1) (±SD) | 0.405±0.141 | 0.386±0.197 | 0.415±0.111 | 0.423±0.178 | 0.384±0.197 | 0.312±0.222 |
| Duration of diabetes (months) | 7.09±2.45 | 7.14±2.44 | 5.61±1.01 | 5.83±1.27 | 10.4±1.13 | 9.76±2.1 |
| Baseline | 6.37±0.787*** | 7.14±1.21 | 6.28±0.709 | 7.34±1.17 | 6.55±0.94 | 6.62±1.22 |
| HbA1c (%)(mmol/m ol) (±SD) | (46.1±8.6) | (54.1±13.1) | (45.2±7.45)*** | (56.7±12.8) | (48.1±10.32) | (48.9±13.3) |
| Positive for anti-GAD65 antibody (%) | 74 | 55 | 70 | 90 | 80 | 63 |
| Positive for anti-IA-2 antibody (%) | 87 | 73 | 86 | 83 | 80 | 50 |
***
p<0.01