Table 1.
Baseline characteristics of the treatment groups, including all 114 subjects correctly randomized
| MMF + DZB |
MMF alone |
|||
|---|---|---|---|---|
| Active | Control | Active | Control | |
| n | 41 | 42 | 31 | 28 |
| Age (years) | 18.3 ± 9.1 | 18.8 ± 10.5 | 17.1 ± 6.7 | 15.8 ± 8.0 |
| Race (% white) | 38 (93) | 39 (93) | 30 (97) | 27 (96) |
| Non-Hispanic (%) | 40 (98) | 39 (93) | 29 (94) | 26 (93) |
| Number of Ab+ (%) | ||||
| 1 | 1 (2) | 3 (7) | 4 (13) | 1 (4) |
| 2 | 11 (27) | 8 (19) | 7 (23) | 7 (25) |
| 3 | 12 (29) | 16 (38) | 6 (19) | 11 (39) |
| 4 | 17 (41) | 15 (36) | 14 (45) | 9 (32) |
| Male sex (%) | 23 (56) | 25 (60) | 20 (65) | 16 (57) |
| 2-h C-peptide AUC means (pmol/ml) | 0.71 ± 0.36 | 0.71 ± 0.34 | 0.65 ± 0.28 | 0.73 ± 0.36 |
| Baseline A1C (%) | 7.5 ± 1.3 | 7.7 ± 1.6 | 7.4 ± 1.0 | 7.5 ± 1.5 |
| Baseline total insulin dose/kg | 0.40 ± 0.26 | 0.36 ± 0.20 | 0.35 ± 0.15 | 0.39 ± 0.22 |
| Weight (kg) | 58.9 ± 16.6 | 59.0 ± 16.3 | 61.3 ± 18.3 | 57.2 ± 16.7 |
| Height (cm) | 162.4 ± 13.5 | 162.7 ± 13.7 | 164.4 ± 15.4 | 160.9 ± 13.4 |
| BMI (kg/m2) | 22.0 ± 4.2 | 21.8 ± 3.6 | 22.1 ± 4.1 | 21.6 ± 4.0 |
| zBMI (only on subjects <20 years) | 0.44 ± 1.11 | 0.66 ± 0.79 | 0.42 ± 1.02 | 0.57 ± 0.74 |
| n | 30 | 28 | 21 | 23 |
| Mean A1C over 24 months (%) | 7.2 ± 1.2 | 7.2 ± 1.0 | 7.0 ± 1.2 | 7.3 ± 0.9 |
| Mean insulin dose/kg over 24 months | 0.56 ± 0.29 | 0.55 ± 0.32 | 0.59 ± 0.31 | 0.63 ± 0.34 |
| Mean MPA level over 24 months (mcg/ml)* | 4.5 ± 3.4 | 0.6 ± 0.6 | 5.8 ± 4.0 | 0.6 ± 0.2 |
| Received 2 full DZB infusions (%) | 40 (98)** | 42 (100) | 31 (100) | 28 (100) |
| % of subjects MMF compliant*** | 36 (88) | 41 (98) | 27 (87) | 27 (96) |
Means ± SD are presented for continuous variables.
*Limit of quantitation = 0.5 units.
**One subject did not receive the second infusion due to patient decision to continue study treatment.
***80% or greater by capsule count up through last recorded visit starting with month 3.