Table 2.
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