Table 3

Safety

Patients withiGlarLixi (n = 469)iGlar (n = 467)Lixi (n = 233)
At least one treatment-emergent AE
 Any AE267 (56.9)227 (48.6)157 (67.4)
 Serious AE18 (3.8)19 (4.1)9 (3.9)
 AE leading to death*2 (0.4)3 (0.6)1 (0.4)
 AE leading to discontinuation12 (2.6)9 (1.9)21 (9)
AE by organ class
 Gastrointestinal disorders (overall)102 (21.7)59 (12.6)86 (36.9)
  Nausea45 (9.6)17 (3.6)56 (24.0)
   Discontinuation due to nausea2 (0.4)06 (2.6)
  Vomiting15 (3.2)7 (1.5)15 (6.4)
   Discontinuation due to vomiting2 (0.4)04 (1.7)
  Diarrhea42 (9.0)20 (4.3)21 (9.0)
   Discontinuation due to diarrhea1 (0.2)02 (0.9)
Hypoglycemia
 Documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL [3.9 mmol/L])
  Patients with events120 (25.6)110 (23.6)15 (6.4)
  Number of events per patient-year1.41.20.3
 Documented symptomatic hypoglycemia (plasma glucose <60 mg/dL [3.3 mmol/L])
  Patients with events66 (14.1)50 (10.7)6 (2.6)
  Number of events per patient-year0.50.30.1
 Severe symptomatic hypoglycemia
  Patients with events01 (0.2)0
  Number of events per patient-year0<0.010
  • Data are n (%) unless otherwise indicated.

  • *See Supplementary Data.

  • †Calculated as number of events divided by total patient-years of exposure. Patient-years of exposure calculated as time from the first to the last injection of investigational drug plus 1 day. Documented symptomatic hypoglycemia = typical symptoms of hypoglycemia accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L) or <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia = requiring another person’s assistance to actively administer carbohydrate, glucagon, or other resuscitative actions. On-treatment period 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.