Table 3

Symptomatic hypoglycemia by background therapy during the on-treatment period (safety population)

Basal insulin + OADsMet + OADs (except SU)SU + Met + other OADs
Placebo (n = 55)Lixi (n = 54)Placebo (n = 57)Lixi (n = 52)Placebo (n = 51)Lixi (n = 59)
Symptomatic hypoglycemia
 Patients with events7 (12.7)3 (5.6)1 (1.8)1 (1.9)2 (3.9)7 (11.9)
 Patients with events per 100 patient-years*29.312.23.74.58.826.7
 Events9711218
 Events per 100 patient-years37.728.63.74.58.868.7
Documented symptomatic hypoglycemia <3.3 mmol/L
 Patients with events7 (12.7)3 (5.6)1 (1.8)1 (1.9)2 (3.9)6 (10.2)
 Patients with events per 100 patient-years*29.312.23.74.58.822.9
 Events9711215
 Events per 100 patient-years37.728.63.74.58.857.2
  • Data are n or n (%). Lixi, lixisenatide; Met, metformin; SU, sulfonylurea.

  • *Calculated as number of patients with events × 100/total exposure + 3 days in patient-years.

  • †Calculated as number of events × 100/total exposure + 3 days in patient-years.

  • ‡Three patients receiving lixisenatide and SU + Met + other OADs had no blood glucose reported.