Table 1

Baseline demographics (randomized population)

Gla-300Gla-100
n = 404n = 407
Age, years57.9 (9.1)58.5 (9.2)
Sex (male), n (%)187 (46.3)185 (45.5)
Ethnic group, n (%)
 Caucasian378 (93.6)383 (94.1)
 Black20 (5.0)16 (3.9)
 Asian/Oriental3 (0.7)7 (1.7)
 Other3 (0.7)1 (0.2)
Body weight, kg98.7 (22.3)98.0 (20.8)
BMI, kg/m234.8 (6.6)34.8 (6.1)
Duration of diabetes, years12.7 (7.1)12.5 (7.0)
Duration of basal insulin treatment, years3.78 (3.73)3.83 (3.34)
Previous basal insulin dose
 units/kg/day0.66 (0.22)0.68 (0.25)
 units/day64.07 (25.59)65.69 (26.14)
Previous basal insulin, n (%)
 Insulin glargine301 (74.9)332 (82.8)
 NPH101 (25.1)69 (17.2)
Previous basal insulin injections, n (%)
 Once daily315 (78.4)322 (80.1)
 Twice daily83 (20.6)76 (18.9)
 More than twice daily4 (1.0)4 (1.0)
Prior use of insulin glargine, n (%)304 (75.2)337 (82.8)
OAD treatment*, n (%)
 Biguanides383 (94.8)381 (93.6)
 Dipeptidyl peptidase 4 inhibitors31 (7.7)51 (12.5)
 Sulfonylureas8 (2.0)2 (0.5)
 Thiazolidinediones6 (1.5)14 (3.4)
 Combinations of OADs5 (1.2)10 (2.5)
 Other11 (2.7)16 (3.9)
HbA1c
 %8.26 (0.86)8.22 (0.77)
 mmol/mol66.8 (9.4)66.3 (8.4)
  • Data are mean (SD) unless otherwise specified.

  • *OAD treatment was continued at stable doses during the study on-treatment period, with the exception of sulfonylureas, which were to be stopped 2 months before randomization according to protocol. Eight participants in the Gla-300 group and two participants in the Gla-100 group did not discontinue sulfonylurea treatment at randomization, and a further one participant in each group commenced sulfonylurea treatment during the study, representing protocol violations.