Table 2.
Summary of HbA1c and Insulin Dose for Participants with and Without Treatment-Emergent Anti-Insulin Antibodies in SORELLA 1 and SORELLA 2/Anti-Insulin Antibody Populations
| Treatment-emergent AIA | ||||||||
|---|---|---|---|---|---|---|---|---|
| SORELLA 1 (52 weeks) | SORELLA 2 (26 weeks) | |||||||
| Yesa | No | Yesa | No | |||||
| SAR-Lis (N = 56) | Ly-Lis (N = 61) | SAR-Lis (N = 192) | Ly-Lis (N = 191) | SAR-Lis (N = 46) | Ly-Lis (N = 36) | SAR-Lis (N = 199) | Ly-Lis (N = 211) | |
| HbA1c (%) | ||||||||
| Baseline | 8.18 (0.74) | 7.97 (0.64) | 8.05 (0.79) | 8.01 (0.64) | 7.92 (0.87) | 7.92 (0.93) | 8.02 (0.86) | 8.04 (0.91) |
| Week 52/26 | 7.92 (1.05) | 7.66 (0.91) | 7.77 (0.96) | 7.72 (0.98) | 7.08 (0.83) | 7.25 (1.02) | 7.05 (0.86) | 7.15 (0.86) |
| LS mean (SE) change from baseline to week 52/26 | –0.14 (0.12) | –0.33 (0.11) | –0.25 (0.07) | –0.29 (0.07) | –0.88 (0.12) | –0.74 (0.13) | –0.93 (0.06) | –0.85 (0.06) |
| LS mean differenceb (SE) vs. Ly-Lis [95% CI] | 0.19 (0.17) [−0.14 to 0.52] | 0.04 (0.09) [−0.14 to 0.22] | −0.15 (0.18) [−0.49 to 0.20] | −0.07 (0.08) [−0.23 to 0.09] | ||||
| Mean daily insulin dose (U/kg) | ||||||||
| Basal insulin | ||||||||
| Baseline | 0.34 (0.16) | 0.31 (0.14) | 0.34 (0.21) | 0.34 (0.14) | 0.46 (0.22) | 0.52 (0.22) | 0.48 (0.27) | 0.44 (0.23) |
| Week 52/26 | 0.45 (0.82) | 0.36 (0.15) | 0.36 (0.23) | 0.34 (0.16) | 0.54 (0.24) | 0.57 (0.25) | 0.56 (0.32) | 0.52 (0.27) |
| Change from baseline to week 52/26 | 0.14 (0.78) | 0.04 (0.07) | 0.02 (0.07) | 0.00 (0.06) | 0.07 (0.09) | 0.07 (0.09) | 0.08 (0.14) | 0.07 (0.13) |
| Mealtime insulin | ||||||||
| Baseline | 0.39 (0.18) | 0.35 (0.13) | 0.36 (0.18) | 0.36 (0.18) | 0.44 (0.27) | 0.47 (0.28) | 0.46 (0.30) | 0.43 (0.32) |
| Week 52/26 | 0.38 (0.15) | 0.35 (0.17) | 0.38 (0.18) | 0.36 (0.17) | 0.49 (0.24) | 0.56 (0.49) | 0.53 (0.35) | 0.50 (0.41) |
| Change from baseline to Week 52/26 | 0.01 (0.12) | 0.01 (0.10) | 0.02 (0.12) | 0.01 (0.11) | 0.04 (0.16) | 0.10 (0.28) | 0.10 (0.22) | 0.08 (0.24) |
| Total insulin | ||||||||
| Baseline | 0.73 (0.29) | 0.66 (0.22) | 0.70 (0.32) | 0.70 (0.25) | 0.90 (0.37) | 0.99 (0.40) | 0.94 (0.49) | 0.86 (0.45) |
| Week 52/26 | 0.72 (0.22) | 0.72 (0.29) | 0.73 (0.30) | 0.70 (0.27) | 1.02 (0.35) | 1.14 (0.64) | 1.09 (0.60) | 1.02 (0.57) |
| Change from baseline to week 52/26 | 0.03 (0.17) | 0.05 (0.12) | 0.04 (0.13) | 0.01 (0.13) | 0.12 (0.21) | 0.18 (0.30) | 0.18 (0.31) | 0.15 (0.30) |
Data are mean (SD) unless otherwise stated.
LS, least square; SAR-Lis, SAR342434; SE, standard error.
Participants with preexisting AIAs that were boosted to a significant higher titer (at least fourfold increase) compared to baseline, or participants without preexisting AIA (or missing baseline) and with at least one positive AIA sample.
Mixed-effect model for repeated measures with treatment group (SAR-Lis, Ly-Lis), randomization strata of screening HbA1c (<8.0, ≥8.0%) and prior use of Humalog/Liprolog (Yes, No), visit (week 12, 26, as well as week 40 and 52 for SORELLA 1), treatment-by-visit interaction, AIA subgroup, AIA subgroup-by-treatment interaction, AIA subgroup-by-visit interaction, and AIA subgroup-by-visit-by-treatment interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.