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. 2017 Nov 16;9(1):373–382. doi: 10.1007/s13300-017-0336-6

Table 2.

Subpopulation analyses at Week 30 for 30-week completers of the LixiLan-L trial (30-week completers from the modified intent-to-treat population)

Parameters iGlarLixi iGlar
All completers HbA1c ≤ 8% 8% < HbA1c ≤ 9% HbA1c > 9% All completers HbA1c ≤ 8% 8% < HbA1c ≤ 9% HbA1c > 9%
HbA1c (n) 325 97 159 69 331 94 157 80
 LS mean change ± SEa − 1.67 ± 0.07 − 1.09 ± 0.10 − 1.44 ± 0.09 − 2.41 ± 0.12 − 1.14 ± 0.07 − 0.53 ± 0.10 − 1.03 ± 0.09 − 1.75 ± 0.11
 LS mean difference ± SEb − 0.54 ± 0.06 − 0.56 ± 0.12 − 0.41 ± 0.10 − 0.66 ± 0.14
 95% confidence interval − 0.66, − 0.42 − 0.80, − 0.31 − 0.59, − 0.22 − 0.93, − 0.39
 p value < 0.0001 < 0.0001 < 0.0001 < 0.0001
Dose (n) 327c 97 161c 69 333 94 158 81
 Mean iGlar dose ± SD (U/day) 47 ± 13 48 ± 12 46 ± 13 47 ± 12 47 ± 12 44 ± 12 47 ± 12 49 ± 12
 Mean Lixi dose ± SD (µg/day) 17 ± 3 17 ± 3 17 ± 3 17 ± 3

SE Standard error

aLeast squares (LS) mean change from screening was estimated using an analysis of covariance (ANCOVA) (all completers) or analysis of variance (ANOVA) (HbA1c subcategories) model, with treatment groups, randomization strata of HbA1c (< 8, ≥ 8%) at Week − 1 (all completers only), randomization strata of metformin use at screening (Yes, No), subgroup factor (subcategories only), treatment by subgroup factor (subcategories only), and country as fixed effects, and screening HbA1c value as a covariate (all completers only)

biGlarLixi vs. iGlar

cFor analysis of final Lixi dose, overall n = 326; 8% < HbA1c ≤ 9% n = 160