Table 2.
Insulin antibodies in patients
| ≥ 65 years | p value | < 65 years | p value | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| LY IGlar | SA IGlar | LY IGlar | SA IGlar | |||||||
| N | n (%) | N | n (%) | N | N (%) | N | N (%) | |||
| Proportion of patients with detectable antibodies | ||||||||||
| Baseline | 107 | 5 (4.7) | 97 | 1 (1.0) | 0.215 | 258 | 15 (5.8) | 268 | 12 (4.5) | 0.556 |
| 24-week endpoint (LOCF) | 107 | 3 (2.8) | 97 | 3 (3.1) | > 0.999 | 258 | 27 (10.5) | 268 | 19 (7.1) | 0.217 |
| Overalla | 107 | 12 (11.2) | 97 | 4 (4.1) | 0.071 | 258 | 44 (17.1) | 268 | 36 (13.4) | 0.275 |
| N | Median (Q1, Q3) | N | Median (Q1, Q3) | p value | N | Median (Q1, Q3) | N | Median (Q1, Q3) | p value | |
|---|---|---|---|---|---|---|---|---|---|---|
| Endpoint median insulin antibody levels | ||||||||||
| Baseline | 5 | 2.32 (0.44–2.97) | 1 | 0.96 (0.96–0.96) | > 0.999 | 15 | 0.71 (0.46–1.54) | 12 | 0.44 (0.34–0.78) | 0.251 |
| 24-week endpoint (LOCF) | 3 | 1.96 (1.11–5.66) | 3 | 0.45 (0.26–4.38) | 0.383 | 27 | 0.99 (0.38–5.14) | 19 | 0.65 (0.36–2.76) | 0.616 |
Values for N included in the analysis comprised only patients with detected or non-detected insulin antibody levels at baseline and post-baseline
The unit of measurement for insulin antibodies is percent binding
IQR interquartile range, LOCF last observation carried forward, LY IGlar LY2963016 insulin glargine, Q1 25th percentile, Q3 75th percentile, SA IGlar insulin glargine
aOverall refers to measurements taken during the 24-week treatment period and not at any specific visit or at endpoint (LOCF)