Table 1

Baseline demographics and disease characteristics of the randomized population

CharacteristicPlacebo (n = 174)Lixisenatide (n = 176)All (N = 350)
Age (years)74.4 (3.8)74.0 (4.0)74.2 (3.9)
Age ≥75 years, n (%)69 (39.7)62 (35.2)131 (37.4)
Male, n (%)90 (51.7)92 (52.3)182 (52.0)
White, n (%)122 (70.1)128 (72.7)250 (71.4)
BMI (kg/m2)30.1 (4.5)29.9 (3.7)30.0 (4.1)
Body weight (kg)80.1 (16.8)80.8 (14.5)80.5 (15.7)
eGFR, n (%)
 ≥30 to <60 mL/min/1.73 m247 (27.0)50 (28.4)97 (27.7)
 ≥60 mL/min/1.73 m2127 (73.0)126 (71.6)253 (72.3)
FPG (mmol/L)8.9 (2.3)8.8 (2.4)8.9 (2.3)
HbA1c at week −1 (%)8.1 (0.7)8.1 (0.7)8.1 (0.7)
HbA1c at week −1 (mmol/mol)65 (1.1)65 (1.1)65 (1.1)
Duration of diabetes (years)14.6 (7.9)13.6 (7.3)14.1 (7.6)
Age at onset of type 2 diabetes (years)59.7 (8.4)60.4 (8.2)60.1 (8.3)
Diabetic sensory or motor neuropathy, n (%)51 (29.3)58 (33.0)109 (31.1)
Diabetic retinopathy, n (%)21 (12.1)28 (15.9)49 (14.0)
History of cardiovascular/cerebrovascular disorder, n (%)162 (93.1)164 (93.2)326 (93.1)
 Hypertension142 (81.6)146 (83.0)288 (82.3)
 Dyslipidemia116 (66.7)122 (69.3)238 (68.0)
Background therapy by regimen, n (%)
 Basal insulin ± OADs55 (31.6)54 (30.7)109 (31.1)
 Met ± OADs (except SU)57 (32.8)52 (29.5)109 (31.1)
 SU + Met ± OADs51 (29.3)59 (33.5)110 (31.4)
 SU ± OADs (except Met)8 (4.6)11 (6.3)19 (5.4)
 OADs (except Met and SU)1 (0.6)01 (0.3)
 No OAD*2 (1.1)02 (0.6)
Concomitant nondiabetic medications, n (%)
 Renin-angiotensin system agents128 (73.6)130 (73.9)258 (73.7)
 Analgesics112 (64.4)114 (64.8)226 (64.6)
 Lipid-modifying agents108 (62.1)110 (62.5)218 (62.3)
 Topical products for joint and muscular pain104 (59.8)98 (55.7)202 (57.7)
 Antithrombotic agents103 (59.2)94 (53.4)197 (56.3)
  • Data are mean (SD) unless otherwise indicated. Met, metformin; SU, sulfonylurea.

  • *Protocol deviation.