Table 2

Treatment outcomes at baseline and after 26 and 52 weeks of treatment

OutcomeBaseline*26 weeks52 weeks
Glargine (n = 159)BIL (n = 307)Glargine (n = 159)BIL (n = 307)P**Glargine (n = 159)BIL (n = 307)P**
HbA1c, %7.41 ± 0.067.43 ± 0.057.13 ± 0.066.60 ± 0.04<0.0017.20 ± 0.066.75 ± 0.05<0.001
 Change from baseline−0.29 ± 0.06−0.82 ± 0.04−0.22 ± 0.06−0.67 ± 0.05
 LSM difference (95% CI)−0.52 (−0.67 to −0.38)−0.44 (−0.60 to −0.29)
HbA1c, mmol/mol57.5 ± 0.757.7 ± 0.554.4 ± 0.748.7 ± 0.5<0.00155.1 ± 0.750.3 ± 0.5<0.001
 Change from baseline−3.2 ± 0.7−8.9 ± 0.5−2.5 ± 0.7−7.3 ± 0.5
 LSM difference (95% CI)−5.7 (−7.3 to −4.2)−4.9 (−6.5 to −3.2)
FSG, mg/dL128 ± 3135 ± 2120 ± 3104 ± 2<0.001116 ± 3108 ± 20.02
Total hypoglycemia rate1.40 ± 0.301.08 ± 0.161.98 ± 0.191.55 ± 0.130.051.62 ± 0.151.24 ± 0.100.03
Total hypoglycemia incidence§30 (18.9)51 (16.8)128 (80.5)232 (76.3)0.35132 (83.0)244 (80.3)0.54
Nocturnal hypoglycemia rate0.62 ± 0.160.53 ± 0.121.04 ± 0.150.43 ± 0.06<0.0010.88 ± 0.140.35 ± 0.06<0.001
Nocturnal hypoglycemia incidence§18 (11.3)25 (8.2)99 (62.3)140 (46.1)0.001107 (67.3)153 (50.3)<0.001
Documented symptomatic hypoglycemia rate0.51 ± 0.150.58 ± 0.120.90 ± 0.150.78 ± 0.100.470.77 ± 0.120.60 ± 0.070.21
Documented symptomatic hypoglycemia incidence§13 (8.2)29 (9.5)88 (55.3)160 (52.6)0.54998 (61.6)176 (57.9)0.411
Documented symptomatic nocturnal hypoglycemia rate0.25 ± 0.110.27 ± 0.091.17 ± 0.570.38 ± 0.19<0.0010.80 ± 0.300.23 ± 0.09<0.001
Documented symptomatic nocturnal hypoglycemia incidence§7 (4.4)13 (4.3)64 (40.3)86 (28.3)0.00771 (44.7)98 (32.2)0.007
Severe hypoglycemia incidence§001 (0.6)0 (0.0)2 (1.3)0 (0.0)0.12
ALT (IU/L)25.8 ± 1.126.3 ± 0.826.6 ± 1.135.9 ± 0.8<0.00126.4 ± 1.134.3 ± 0.8<0.001
AST (IU/L)22.9 ± 0.723.3 ± 0.523.3 ± 0.828.7 ± 0.5<0.00123.5 ± 0.827.7 ± 0.6<0.001
LDL-C (mg/dL)95.6 ± 2.997.2 ± 2.1100.8 ± 2.096.2 ± 1.40.0699.6 ± 2.092.8 ± 1.50.007
HDL-C (mg/dL)46.4 ± 1.048.0 ± 0.747.3 ± 0.545.7 ± 0.40.00945.4 ± 0.543.9 ± 0.40.02
Non-HDL-C (mg/dL)124.4 ± 3.2126.5 ± 2.3129.0 ± 2.2129.2 ± 1.60.927130.1 ± 2.3127.1 ± 1.60.28
Triglycerides (mg/dL)144 ± 6149 ± 4143 ± 5169 ± 4<0.001158 ± 6174 ± 40.03
Systolic blood pressure (mmHg)132 ± 1132 ± 1135 ± 1134 ± 10.309133 ± 1133 ± 10.930
Diastolic blood pressure (mmHg)76 ± 177 ± 178 ± 178 ± 00.89977 ± 178 ± 00.601
Treatment-emergent antibody response9 (6.3)33 (11.7)0.08913 (9.7)27 (10.4)0.85
LFC (%)#10.0 ± 1.110.4 ± 0.89.1 ± 0.715.1 ± 0.5<0.0019.6 ± 0.814.9 ± 0.5<0.001
Abdominal visceral-to-subcutaneous fat ratio#††0.720.680.690.720.0010.680.74<0.001
  • n reflects maximal sample size.

  • *No between-treatment differences (P > 0.05) in any baseline parameter.

  • †LSM ± SE.

  • ‡Group mean ± SE.

  • §Number of patients (%).

  • ‖For hypoglycemia rate data, values shown are events/patients/30 days for baseline to week 26 and baseline to week 52.

  • ¶Treatment-emergent anti-BIL antibody response is defined as change from baseline to postbaseline in the anti-BIL antibody level either 1) from undetectable to detectable and the postbaseline value ≥1% + cut point or 2) from detectable to the value with a relative change ([postbaseline − baseline]/baseline) ≥30% and absolute change ≥1%.

  • #N = 52 for glargine; N = 110 for BIL.

  • **Between-treatment differences.

  • ††LSM.