Table 2.

Pharmacodynamic characteristics after a single dose in (A) the Japanese and (B) the European study

(A)	Gla-100 0.4 U/kg	Gla-300 0.4 U/kg	Gla-300 0.6 U/kg
Number	18	18	18
Mean ± s.d. GIR-AUC0–36, mg/kg	1859 ± 1085	990 ± 1233†	1591 ± 1719†
Mean ± s.d. GIRmax, mg/kg/min*	2.2 ± 0.8	1.2 ± 1.0†	1.8 ± 1.3†
Median (interquartile range) T50%-GIR-AUC0–36, h	13 (10–15)	17 (14–21)‡§	18 (15–21)‡

(B)	Gla-100 0.4 U/kg	Gla-300 0.4 U/kg	Gla-300 0.6 U/kg	Gla-300 0.9 U/kg
Number	22	22**	22††	22
Mean ± s.d. GIR-AUC0–24, mg/kg	1480 ± 810	383 ± 379†	728 ± 779†	1179 ± 608
Mean ± s.d. GIR-AUC0–36, mg/kg	1725 ± 920	631 ± 590†	1118 ± 1018†	1845 ± 765
Mean ± s.d. GIRmax, mg/kg/min*	2.2 ± 0.9	1.6 ± 1.1†	1.5 ± 0.9	2.2 ± 0.7
Median (interquartile range) T50%-GIR-AUC0–36, h	12 (11–13)	17 (12–24)‡	17 (14–23)‡	19 (18–22)‡
Median (interquartile range) T50%-GIR-AUC0–24, h	11 (10–12)	11 (8–14)	13 (11–13)	13 (12–15)

GIR, glucose infusion rate; GIR-AUC_0–24/36, area under the body-weight-standardized GIR time curve from time 0 to 24 or 36 h; GIR_max, maximum smoothed body-weight-standardized GIR; T_50%-GIR-AUC_0–36, time to 50% of GIR-AUC_0–36; s.d., standard deviation.

^*LOESS smoothing factor of 0.06.

^†Statistically significantly different from insulin glargine 100 U/ml 0.4 U/kg: concluded if p-value <0.05.

^‡Statistically significantly different from insulin glargine 100 U/ml 0.4 U/kg: for T_50%-GIR-AUC_0–36, concluded if p-value <0.1. No inferential analysis was performed for T_50%-GIR-AUC_0–24.

^§N = 14 (4 of 18 subjects with no GIR were excluded).

^**Three of 22 subjects received rescue insulin, after which GIR was set to ‘missing’.

^††Two of 22 subjects received rescue insulin, after which GIR was set to ‘missing’.