Table 3

AEs and hypoglycemic events

Patients (n [%]) withiGlarLixi (n = 365)iGlar (n = 365)
At least one TEAE
 Any TEAE195 (53.4)191 (52.3)
 Serious TEAE20 (5.5)18 (4.9)
 TEAE leading to death1 (0.3)2 (0.5)
 TEAE leading to discontinuation10 (2.7)3 (0.8)
AE by organ class in ≥5% of patients
 Infections and infestations98 (26.8)112 (30.7)
 Nervous system disorders39 (10.7)19 (5.2)
 Gastrointestinal disorders (overall)62 (17.0)29 (7.9)
  Nausea38 (10.4)2 (0.5)
   Discontinuation due to nausea4 (1.1)0
  Vomiting13 (3.6)2 (0.5)
   Discontinuation due to vomiting00
  Diarrhea16 (4.4)10 (2.7)
   Discontinuation due to diarrhea00
Documented hypoglycemia
 Symptomatic*
  Patients with events, n (%)146 (40.0)155 (42.5)
  Events per patient-year, n3.034.22
 Severe
  Patients with events, n (%)4 (1.1)1 (0.3)
  Events per patient-year, n0.02<0.01
  Event rate ratio (95% CI) vs. iGlar0.77 (0.55–1.07)
  • Patient-years of exposure were calculated as the time from the first to the last injection of the investigational drug plus 1 day. Symptomatic hypoglycemia defined as symptomatic hypoglycemia recorded on the dedicated electronic case report form and meeting the protocol definition for severe or documented hypoglycemia. On-treatment period is defined as the time from the first injection of investigational drug up to 1 day for symptomatic hypoglycemia after the last injection of investigational drug, regardless of the introduction of rescue therapy. TEAE, treatment-emergent AE.

  • *Defined as plasma glucose ≤70 mg/dL [≤3.9 mmol/L]).

  • †Calculated as number of events divided by total patient-years of exposure.

  • ‡In these cases, most had confounding circumstances that likely contributed to the development of the event, such as excessive exercise and diminished oral intake before the events.