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Table 3 Summary of Local and Systemic Allergic Reactionsa and Incidenceb of Hypoglycemic Events (Safety Population)

From: Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies

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)
  1. T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus
  2. aA patient was counted only once if the patient had multiple injection site reactions or signs/symptoms in the same location
  3. bIncidence was defined as a patient who experienced at least 1 episode of a hypoglycemic event