Table 3 Summary of Local and Systemic Allergic Reactionsa and Incidenceb of Hypoglycemic Events (Safety Population)
n (%) | INSTRIDE 1 (T1DM) | INSTRIDE 2 (T2DM) | ||
|---|---|---|---|---|
MYL‑1501D (n=280) | Reference insulin glargine (n=278) | MYL‑1501D (n=276) | Reference insulin glargine (n=282) | |
Patient with reaction | 5 (1.8) | 6 (2.2) | 4 (1.4) | 2 (0.7) |
Local | 3 (1.1) | 4 (1.4) | 2 (0.7) | 1 (0.4) |
Systemic | 2 (0.7) | 2 (0.7) | 2 (0.7) | 1 (0.4) |
Hypoglycemic incidence | 273 (97.5) | 269 (96.8) | 130 (47.1) | 136 (48.2) |
Severe hypoglycemic incidence | 11 (3.9) | 13 (4.7) | 0 (0) | 1 (0.4) |