Table 3.
Adverse events, n (%) | ≥ 65 years | p value | < 65 years | p value | Treatment-by-age subgroup interaction | ||
---|---|---|---|---|---|---|---|
LY IGlar N = 112 | SA IGlar N = 102 | LY IGlar N = 264 | SA IGlar N = 278 | ||||
Patients with ≥ 1 TEAE | 63 (56.3) | 56 (54.9) | 0.843 | 133 (50.4) | 128 (46.0) | 0.313 | 0.714 |
Special topic assessmenta | 5 (4.5) | 7 (6.9) | 0.447 | 16 (6.1) | 20 (7.2) | 0.597 | 0.695 |
Injection site reactions | 4 (3.6) | 1 (1.0) | 0.211 | 9 (3.4) | 8 (2.9) | 0.723 | 0.337 |
Patients with ≥ 1 SAE | 8 (7.1) | 11 (10.8) | 0.351 | 7 (2.7) | 7 (2.5) | 0.922 | 0.487 |
INT interaction, LY IGlar LY2963016 insulin glargine, N number of evaluable patients, n number of patients with TEAE, SAE serious adverse event, SA IGlar insulin glargine, TEAE treatment-emergent adverse event
aCategories of adverse events also include special topic assessment of adverse (allergic) events, injection site reactions, and SAEs though overall events are less than 5%