Table 2

Response to therapy

Efficacy end pointiGlarLixi (n = 366)iGlar (n = 365)
HbA1c, % (mmol/mol)
 Baseline8.1 ± 0.7 (65)8.1 ± 0.7 (65)
 Week 306.9 ± 0.9 (52)7.5 ± 0.9 (58)
 LS mean ± SE change from baseline*−1.1 ± 0.06−0.6 ± 0.06
 LS mean ± SE difference vs. iGlar*−0.5 ± 0.06
 95% CI−0.6, –0.4
 P value<0.0001
HbA1c <7.0% (53 mmol/mol) at week 30
 n (%)201 (54.9)108 (29.6)
 Difference from iGlar, %25.5
 95% CI18.9, 32.1
 P value<0.0001
HbA1c ≤6.5% (48 mmol/mol) at week 30
 n (%)124 (33.9)52 (14.2)
 Difference from iGlar, %19.8
 95% CI13.9, 25.6
 P value<0.0001
2-h plasma glucose excursion, mmol/L
 Baseline7.0 ± 3.57.1 ± 3.1
 Week 30 (LOCF)3.1 ± 3.66.7 ± 3.3
 LS mean ± SE change from baseline−3.9 ± 0.3−0.5 ± 0.3
 LS mean ± SE difference vs. iGlar−3.4 ± 0.3
 95% CI−3.9, –2.9
 P value<0.0001
2-h PPG, mmol/L
 Baseline14.9 ± 3.815.0 ± 3.7
 Week 30 (LOCF)9.9 ± 3.913.4 ± 3.8
 LS mean ± SE change from baseline−4.7 ± 0.3−1.4 ± 0.3
 LS mean ± SE difference vs. iGlar−3.3 ± 0.3
 95% CI−3.9, –2.8
FPG, mmol/L
 Baseline7.3 ± 1.97.3 ± 2.1
 Week 306.8 ± 2.36.7 ± 2.1
 LS mean ± SE change from baseline*−0.4 ± 0.1−0.5 ± 0.1
 LS mean ± SE difference vs. iGlar*0.1 ± 0.2
 95% CI−0.2, 0.4
 P value0.495
Weight, kg
 Baseline87.8 ± 14.487.1 ± 14.8
 Week 3087.5 ± 14.488.0 ± 15.1
 LS mean ± SE change from baseline*−0.7 ± 0.20.7 ± 0.2
 LS mean ± SE difference vs. iGlar*−1.4 ± 0.2
 95% CI−1.8, –0.9
 P value<0.0001
7-point SMPG, mmol/L
 Baseline9.2 ± 1.69.1 ± 1.6
 Week 307.8 ± 1.78.6 ± 1.7
 LS mean ± SE change from baseline*−1.5 ± 0.1−0.6 ± 0.1
 LS mean ± SE difference vs. iGlar*−0.9 ± 0.1
 95% CI−1.2, –0.6
 P value<0.0001
HbA1c <7.0% (53 mmol/mol)
 Without weight gain at week 30
  n (%)125 (34.2)49 (13.4)
  Proportion difference vs. iGlar, %20.8
  95% CI15.0, 26.7
  P value<0.0001
 Without documented symptomatic hypoglycemia
  n (%)116 (31.7)68 (18.6)
  Proportion difference vs. iGlar, %13.2
  95% CI7.1, 19.3
 Without weight gain and documented symptomatic hypoglycemia
  n (%)73 (19.9)33 (9.0)
  Proportion difference vs. iGlar, %10.9
  95% CI5.9, 16.0
  P value<0.0001
Daily iGlar dose, units
 Start of run-in (SD)27.3 (8.1)27.7 (8.0)
 Baseline35.0 ± 9.235.2 ± 8.6
 Week 3046.7 ± 12.646.7 ± 12.5
 LS mean ± SE change from baseline*10.6 ± 0.610.9 ± 0.6
 LS mean ± SE difference vs. iGlar*−0.3 (0.8)
 95% CI−1.8, 1.3
 P value0.736
  • Data are presented as the mean ± SD, or as indicated. Data are provided in mg/dL in Supplementary Table 1.

  • LOCF, last observation carried forward; LS, least squares.

  • *Mixed-effect model with repeated measures;

  • †Cochran-Mantel-Haenszel method;

  • ‡ANCOVA model. The 2-h PG excursion = 2-h PPG – PG 30 min before the meal and before investigational medicinal product injection (only at week 30).