Table 2.
Baseline and endpoint values for HbA1c, insulin dose, and body weight by treatment-by-upper quartile of the maximum antibody percent binding
| UQMAPB–yes | UQMAPB–no | |||||
|---|---|---|---|---|---|---|
| LY IGlar | IGlar | p value | LY IGlar | IGlar | p value | |
| ELEMENT-1 (T1D) | ||||||
| Evaluable patientsa | N = 265 | N = 267 | N = 265 | N = 267 | ||
| Patients in UQMAPB | (Yes) n = 29 | (Yes) n = 24 | (No) n = 236 | (No) n = 243 | ||
| Baseline HbA1c (%) | 7.71 (0.20) | 7.84 (0.22) | 0.663 | 7.75 (0.07) | 7.78 (0.07) | 0.722 |
| Endpoint HbA1c (%) | 7.58 (0.14) | 7.62 (0.15) | 0.834 | 7.49 (0.06) | 7.48 (0.06) | 0.844 |
| Baseline basal insulin dose (U/kg/day) | 0.36 (0.03) | 0.31 (0.03) | 0.277 | 0.32 (0.01) | 0.31 (0.01) | 0.305 |
| Endpoint basal insulin dose (U/kg/day) | 0.39 (0.03) | 0.34 (0.03) | 0.158 | 0.38 (0.01) | 0.36 (0.01) | 0.321 |
| Baseline basal insulin lispro dose (U/kg/day) | 0.37 (0.04) | 0.38 (0.04) | 0.833 | 0.40 (0.01) | 0.40 (0.02) | 0.790 |
| Endpoint basal insulin lispro dose (U/kg/day) | 0.45 (0.04) | 0.38 (0.04) | 0.181 | 0.36 (0.02) | 0.37 (0.02) | 0.530 |
| Baseline total insulin dose (U/kg/day) | 0.69 (0.05) | 0.69 (0.05) | 0.956 | 0.72 (0.02) | 0.71 (0.02) | 0.664 |
| Endpoint total insulin dose (U/kg/day) | 0.84 (0.05) | 0.71 (0.06) | 0.081 | 0.74 (0.02) | 0.74 (0.02) | 0.908 |
| Baseline body weight (kg) | 77.5 (3.0) | 74.1 (3.3) | 0.453 | 75.7 (1.05) | 74.8 (1.0) | 0.547 |
| Endpoint body weight (kg) | 77.6 (2.8) | 72.2 (3.1) | 0.179 | 74.2 (1.2) | 73.3 (1.2) | 0.506 |
| ELEMENT-2 (T2D) | ||||||
| Evaluable patientsa | N = 365 | N = 365 | N = 365 | N = 365 | ||
| Patients in UQMAPB | (Yes) n = 14 | (Yes) n = 10 | (No) n = 351 | (No) n = 355 | ||
| Baseline HbA1c (%) | 8.86 (0.29) | 8.38 (0.34) | 0.285 | 8.33 (0.06) | 8.33 (0.06) | 0.969 |
| Endpoint HbA1c (%) | 7.04 (0.24) | 6.94 (0.28) | 0.786 | 7.07 (0.07) | 7.02 (0.07) | 0.377 |
| Baseline basal insulin dose (U/kg/day) | 0.12 (0.06) | 0.02 (0.08) | 0.298 | 0.16 (0.01) | 0.14 (0.01) | 0.184 |
| Endpoint basal insulin dose (U/kg/day) | 0.52 (0.10) | 0.51 (0.11) | 0.921 | 0.50 (0.03) | 0.48 (0.03) | 0.437 |
| Baseline body weight (kg) | 79.9 (5.2) | 84.9 (6.2) | 0.540 | 90.8 (1.1) | 90.3 (1.1) | 0.744 |
| Endpoint body weight (kg) | 80.2 (5.1) | 87.6 (5.9) | 0.324 | 85.7 (1.4) | 85.0 (1.4) | 0.611 |
Data are least squares mean ± standard error
HbA1c glycated hemoglobin, IGlar insulin glargine, LY IGlar LY2963016 insulin glargine, UQMAPB upper quartile of maximum antibody percent binding, T1D type 1 diabetes, T2D type 2 diabetes
aDefined as patients having “detected” or “nondetected” insulin antibody levels at baseline and postbaseline visit (patients at risk of treatment-emergent antibody response)