Table 1.

Pharmacokinetic 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	15*	18
Mean ± s.d. INS-Cmax, µU/ml	17.3 ± 4.8	10.9 ± 3.4†	13.8 ± 7.1†
Mean ± s.d. INS-AUC0–24, µU·h/ml	303 ± 79	190 ± 67†	232 ± 123†
Mean ± s.d. INS-AUC0–36, µU·h/ml	370 ± 101	251 ± 92†	326 ± 156†
Median (interquartile range) T50%-INS-AUC0–36, h	14 (12–15)	17 (13–19)‡	18 (16–18)‡
Median (interquartile range) INS-Tmax, h	8 (2–12)	16 (12–16)‡	14 (8–16)‡

(B)	Gla-1000.4 U/kg	Gla-3000.4 U/kg	Gla-3000.6 U/kg	Gla-3000.9 U/kg
Number	22	15§	20¶	22
Mean ± s.d. INS-Cmax, µU/ml	15.3 ± 6.0	8.9 ± 2.9†	9.3 ± 2.8†	13.0 ± 6.2
Mean ± s.d. INS-AUC0–24, µU·h/ml	266 ± 92	148 ± 64†	149 ± 76†	222 ± 98
Mean ± s.d. INS-AUC0–36, µU·h/ml	318 ± 109	195 ± 89†	206 ± 105†	327 ± 139
Median (interquartile range) T50%-INS-AUC0-36, h	13 (12–15)	15 (12–19)‡	17 (14–20)‡	19 (17–19)‡
Median (interquartile range) INS-Tmax, h	12 (8–12)	12 (8–14)	12 (12–18)‡	16 (12–20)‡

Gla-100, insulin glargine 100 U/ml; Gla-300, insulin glargine 300 U/ml; INS, insulin glargine concentration; INS-C_max, maximum serum insulin concentration; INS-AUC_0–24/36, area under the concentration versus time curve from time 0 to 24 or 36 h; INS-T_max, time to INS-C_max; T_50%-INS-AUC_0–36, time to 50% of INS-AUC_0–36; s.d., standard deviation; LLOQ, lower limit of quantification.

Note: Normality assumptions were not always met, limiting interpretability of p values for certain cases.

^*Three of 18 participants on rescue insulin were excluded from the analysis.

^†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%-INS-AUC_0–36 and INS-T_max, concluded if p value < 0.1.

^§Seven of 22 participants with INS < LLOQ.

^¶Two of 22 participants with INS < LLOQ.