Table 2

Glycemic control (ITT population)

Efficacy parametersGla-300 (N = 462)IDeg-100 (N = 462)
HbA1c
 Baseline
  %8.72 ± 0.838.57 ± 0.80
  mmol/mol71.8 ± 9.170.2 ± 8.8
 Week 24
  %7.03 ± 0.797.03 ± 0.77
  mmol/mol53.3 ± 8.653.3 ± 8.4
 LS mean change from baseline to week 24 ± SE
  %−1.64 ± 0.04−1.59 ± 0.04
  mmol/mol−18.0 ± 0.4−17.4 ± 0.4
 LS mean difference (95% CI)
  %−0.05 (−0.15 to 0.05)a
  mmol/mol−0.6 (−1.7 to 0.6)a
Patients who reached HbA1c target <7.0% (<53 mmol/mol), n (%)225 (48.7)206 (44.6)
 OR (95% CI)1.19 (0.91–1.54)
Patients who reached HbA1c target without confirmed (≤70 mg/dL) hypoglycemia, n (%)62 (13.4)60 (13.0)
 OR (95% CI)1.05 (0.71–1.55)
Patients who reached HbA1c target without confirmed (<54 mg/dL) hypoglycemia, n (%)194 (42.0)175 (37.9)
 OR (95% CI)1.20 (0.92–1.57)
FPG, mg/dL
 Baseline190.60 ± 49.36182.12 ± 51.68
 Week 24123.76 ± 40.60114.54 ± 33.23
 LS mean change from baseline to week 24 ± SE−63.47 ± 1.956−71.16 ± 1.977
 LS mean difference (95% CI)7.68 (2.71–12.65)
Fasting SMPG, mg/dL
 Baseline177.85 ± 40.49171.65 ± 38.16
 Week 24115.21 ± 23.66113.29 ± 20.65
 LS mean change from baseline to week 24 ± SE−58.11 ± 1.21−59.18 ± 1.22
 LS mean difference (95% CI)1.08 (−1.94 to 4.10)
  • Baseline and week 24 values are mean ± SD.

  • aPrimary end point; P < 0.0001 for noninferiority (noninferiority margin 0.3%).