Table 1.
Trial | TN-02 | TN-05 | TN-08 | TN-09 | TN-14 | ITN-27 | ITN-28 | ITN-45 |
---|---|---|---|---|---|---|---|---|
Registration number | NCT00100178 | NCT00279305 | NCT00529399 | NCT00505375 | NCT00947427 | NCT00129259 | NCT00515099 | NCT00965458 |
Treatment(s) | Mycophenolate and daclizumab | Rituxumab | GAD s.c. immunisation | Abatacept | Cankinumab | Teplizumab | Anti-thymocyte globulin | Alefacept |
Main Trial Outcome | No preservation of CPAVE | Preserved CPAVE at 12 months | No preservation of CPAVE | Preserved CPAVE at 12 months | No preservation of CPAVE | Preserved CPAVE at 12 months | No preservation of CPAVE | No preservation of CPAVE |
N | 75 | 58 | 105 | 95 | 66 | 73 | 38 | 29 |
Percent males | 60 | 64 | 52 | 57 | 53 | 59 | 63 | 59 |
Percent Hispanic or Latino | 4 | 5 | 8 | 6 | 6 | 3 | 6 | 4 |
Age (years) | 13.5±3.0 | 13.8±2.7 | 12.7±4.3 | 12.6±3.7 | 11.8±3.6 | 12.1±2.7 | 15.9±2.5 | 16.1±2.1 |
Body mass index (kg/m2) | 20.6±3.4 | 21.4±4.2 | 20.0±3.5 | 20.5±4.4 | 20.3±5.0 | 19.5±4.0 | 22.4±2.9 | 22.5±5.7 |
Diabetes duration (days) | 54±21 | 63±22 | 63±18 | 60±18 | 49±21 | 49±7 | 50±20 | 51±23 |
HbA1c (mmol/mol) | 61±15 | 56±12 | 49±11 | 48±9 | 53±12 | 58±12 | 51±12 | 55±16 |
HbA1c (percentage units) | 7.7±1.4 | 7.3±1.1 | 6.6±1.0 | 6.5±0.8 | 7.0±1.1 | 7.5±1.1 | 6.8±1.1 | 7.2±1.5 |
Insulin dose (U/kg) | 0.27±0.26 | 0.42±0.21 | 0.40±0.24 | 0.40±0.26 | 0.38±0.25 | 0.42±0.27 | 0.41±0.26 | 0.38±0.19 |
CPAVE (nmol/L) | 0.68±0.29 | 0.75±0.39 | 0.71±0.30 | 0.75±0.40 | 0.64±0.33 | 0.70±0.31 | 0.98±0.45 | 0.83±0.41 |
Continuous data are mean±SD