Table 4.
Proportion of patients with TEAEs, drop-out rates, and rescue therapy percentage in the EDITION trials (6 mo treatment period).
| Proportion of patients (%) | EDITION 1 | EDITION 2 | EDITION 3 | EDITION 4 | EDITION JP1 | EDITION JP2 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | |
| TEAEs | 56.4 | 54.2 | 58.8 | 50.7 | 56.8 | 55.9 | 60.9 | 58.2 | 62.3 | 64.5 | 58.3 | 56.7 |
| Serious TEAEs | 6.4 | 5.2 | 3.7 | 3.7 | 5.5 | 5.9 | 6.2 | 8.0 | 2.5 | 2.5 | 4.2 | 3.3 |
| TEAEs leading to treatment discontinuation | 1.5 | 1.7 | 1.5 | 1.0 | 1.1 | 1.1 | 1.1 | 1.1 | 0.8 | 0 | 2.5 | 0.8 |
| Drop-out rates %∗ | 7.4 | 7.7 | 8.9 | 9.3 | 14 | 17 | 15.7 | 14.2 | 4.1 | 3.3 | 5.0 | 1.7 |
| Rescue therapy (%) | NA | NA | 5.7 | 4.9 | 3.0 | 2.0 | NA | NA | NA | NA | 1.66 | 0.0 |
| Deaths (n)∗∗ | 1 | 2 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Glar-100: insulin glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; mITT: modified intention to treat; TEAEs: treatment-emergent adverse events. ∗Modified intention-to-treat population; ∗∗none of the deaths were considered to be related to the study drug; in the EDITION 1 and 3 trials, additional deaths occurred after treatment discontinuation.