Table 1

Screening demographic data and patient characteristics: randomized population

ParametersInsulin glargine with or without metformin plus
Lixisenatide 20 µg once daily (n = 298)Insulin glulisine once daily (n = 298)Insulin glulisine thrice daily (n = 298)
Age at screening, years59.8 ± 8.660.2 ± 8.659.4 ± 9.5
Male, n (%)138 (46.3)135 (45.3)132 (44.3)
White, n (%)276 (92.6)280 (94.0)272 (91.3)
BMI, kg/m232.3 ± 4.631.9 ± 4.432.5 ± 4.6
Body weight, kg
 Start of run-in89.8 ± 17.487.9 ± 15.889.7 ± 17.3
 End of run-in90.2 ± 17.588.4 ± 15.890.1 ± 17.3
HbA1c, % (mmol/mol)
 Screening8.5 ± 0.7 (69 ± 7.7)8.5 ± 0.7 (69 ± 7.7)8.5 ± 0.8 (69 ± 8.7)
 End of run-in7.9 ± 0.5 (63 ± 5.5)7.8 ± 0.5 (62 ± 5.5)7.9 ± 0.5 (63 ± 5.5)
FPG, mmol/L (mg/dL)
 Start of run-in9.2 ± 2.9 (165 ± 53)9.3 ± 2.9 (167 ± 52)9.5 ± 3.0 (171 ± 53)
 End of run-in6.9 ± 2.1 (125 ± 37)6.8 ± 1.8 (122 ± 32)6.7 ± 1.9 (119 ± 34)
Variables at screening
 Duration of type 2 diabetes, years11.9 ± 6.412.3 ± 6.812.4 ± 6.8
 Duration of basal insulin treatment, years3.1 ± 2.63.3 ± 3.53.2 ± 3.1
 Daily basal insulin dose, units/day
  NPH insulin41 ± 2039 ± 1841 ± 20
  Insulin glargine42 ± 2341 ± 2340 ± 23
  Insulin detemir41 ± 3040 ± 2539 ± 22
 OAD use, n (%)
  Metformin262 (87.9)260 (87.2)259 (86.9)
  SU141 (47.3)129 (43.3)142 (47.7)
  DPP-4 inhibitor37 (12.4)29 (9.7)42 (14.1)
Insulin glargine dose, units/day
 Start of run-in41 ± 2240 ± 2239 ± 21
 End of run-in68 ± 3265 ± 3265 ± 27
Patients with evening insulin glargine dosing,* %73.576.873.0
Patients with study drug administration at:
 Breakfast, %30.229.5
 Evening meal, %69.569.8
 Missing, %0.30.7
  • Data are presented as the mean ± SD or as indicated.

  • All data are for screening except where indicated otherwise. Start of run-in, week – 12; end of run-in, week – 1.

  • *Data available for 283 lixisenatide-treated patients and 289 patients in each insulin glulisine arm; evening dosing defined as any dose administered between 1600 and 0400 h.