Table 2

Results (mITT population)

Efficacy end pointiGlarLixi (n = 468)iGlar (n = 466)Lixi (n = 233)
HbA1c (%) (mmol/mol)
 Baseline8.1 ± 0.7 (65)8.1 ± 0.7 (65)8.1 ± 0.7 (65)
 Week 306.5 ± 0.8 (48)6.8 ± 0.8 (51)7.3 ± 0.9 (56)
 LS mean ± SE change from baseline*−1.6 ± 0.04−1.3 ± 0.04−0.9 ± 0.05
 LS mean ± SE difference vs. iGlar*−0.3 ± 0.05
  95% CI−0.4 to −0.2
  P value<0.0001
 LS mean ± SE difference vs. Lixi*−0.8 ± 0.06
  95% CI−0.9 to −0.7
  P value<0.0001
HbA1c ≤6.5% (48 mmol/mol) at week 30
 n (%)261 (55.8)184 (39.5)45 (19.3)
 Difference from iGlar (%)16.4
  95% CI10.1 to 22.6
  P value<0.0001
 Difference from Lixi (%)36.4
  95% CI29.8 to 43.0
  P value<0.0001
HbA1c <7.0% (53 mmol/mol) at week 30
 n (%)345 (73.7)277 (59.4)77 (33.0)
 Difference from iGlar (%)14.3
  95% CI8.4 to 20.3
  P value<0.0001
 Difference from Lixi (%)40.6
  95% CI33.6 to 47.6
  P value<0.0001
2-h PPG (mmol/L)
 Baseline15.2 ± 3.614.6 ± 3.614.7 ± 3.3
 Week 30 (LOCF)9.2 ± 3.211.4 ± 3.110.0 ± 3.9
 LS mean ± SE change from baseline−5.7 ± 0.2−3.3 ± 0.2−4.6 ± 0.2
 LS mean ± SE difference vs. iGlar−2.4 ± 0.2
  95% CI§−2.8 to −2.0
 LS mean ± SE difference vs. Lixi−1.1 ± 0.3
  95% CI§−1.6 to −0.6
FPG (mmol/L)
 Baseline9.9 ± 2.39.8 ± 2.39.8 ± 2.2
 Week 30 (LOCF)6.3 ± 1.56.5 ± 1.88.3 ± 2.2
 LS mean ± SE change from baseline*−3.5 ± 0.1−3.3 ± 0.1−1.5 ± 0.1
 LS mean ± SE difference vs. iGlar*−0.2 ± 0.1
  95% CI−0.4 to 0.04
  P value0.1
 LS mean ± SE difference vs. Lixi*−2.0 ± 0.1
  95% CI−2.2 to −1.7
  P value<0.0001
Body weight (kg)
 Baseline89.4 ± 17.289.8 ± 16.390.8 ± 16.3
 Week 3089.2 ± 17.390.7 ± 16.088.6 ± 16.2
 LS mean ± SE change from baseline*−0.3 ± 0.21.1 ± 0.2−2.3 ± 0.3
 LS mean ± SE difference vs. iGlar*−1.4 ± 0.3
  95% CI−1.9 to −0.9
  P value<0.0001
 LS mean ± SE difference vs. Lixi*2.0 ± 0.3
  95% CI§1.4 to 2.6
HbA1c <7.0% (53 mmol/mol) without weight gain at week 30
 n (%)202 (43.2)117 (25.1)65 (27.9)
 Difference vs. iGlar (%)18.1
  95% CI12.2 to 24.0
  P value<0.0001
 Difference vs. Lixi (%)15.2
  95% CI§8.1 to 22.4
HbA1c <7.0% (53 mmol/mol) at week 30 and no documented symptomatic hypoglycemia
 n (%)251 (53.6)207 (44.4)71 (30.5)
 Difference vs. iGlar (%)9.3
  95% CI§3.0 to 15.6
 Difference vs. Lixi (%)23.1
  95% CI§15.8 to 30.3
HbA1c <7.0% (53 mmol/mol), no weight gain at week 30 and no documented symptomatic hypoglycemia
 n (%)149 (31.8)88 (18.9)61 (26.2)
 Difference vs. iGlar (%)13.0
  95% CI7.5 to 18.5
  P value<0.0001
 Difference vs. Lixi (%)5.6
  95% CI§−1.3 to 12.6
  • Data are mean ± SD unless otherwise indicated. LOCF, last observation carried forward.

  • *Mixed-effect model with repeated measures with treatment groups, randomization strata of HbA1c (<8.0%, ≥8.0%), randomization strata of second oral glucose-lowering therapy use at screening, visit, treatment-by-visit interaction, and country as fixed effects and baseline outcome measure value by visit as a covariate.

  • †Weighted average of proportion difference between treatment groups from each strata (randomization strata of HbA1c [<8.0%, ≥8.0%], randomization strata of second oral glucose-lowering therapy use at screening [yes, no]) using Cochran-Mantel-Haenszel weights. Proportion difference = difference of the proportions of patients achieving HbA1c target.

  • ‡ANCOVA model with treatment groups, randomization strata of HbA1c (<8.0%, ≥8.0%), randomization strata of second oral glucose-lowering therapy use at screening, and country as fixed effects and baseline 2-h PPG excursion value as a covariate.

  • §No P value because the comparison was specified in the step-down testing procedure.