Table 1

PK parameters after multiple doses in steady state

Gla-100
0.4 units·kg−1Gla-300
0.4 units·kg−1Treatment ratio
T/R (90% CI)Treatment difference
T − R (90% CI)
n1716§
INS-Cmax, µU·mL−1*23.4 ± 8.418.1 ± 6.50.78 (0.68 to 0.91)
INS-AUC0–24, µU·h·mL−1*389 ± 141331 ± 1400.83 (0.69 to 1.00)
INS-AUC0–36, µU·h·mL−1*438 ± 167418 ± 1860.93 (0.77 to 1.12)
T50%-INS-AUC0–24, h9.6 (9–10)10.4 (10–11)0.65 (0.06 to 1.25)
T50%-INS-AUC0–36, h10.9 (10–12)14.0 (12–15)2.05 (1.35 to 3.03)
INS-t1/2, h*13.5 ± 6.919.0 ± 6.4
ΔINS, µU·mL−1ǁ15 (11–18)9 (5–10)
Swing1.8 (1.3–2.3)0.8 (0.6–1.0)
  • All data shown from cohort 1; Gla-100 0.4 units·kg−1 (reference) versus Gla-300 0.4 units·kg−1 (treatment). Data from cohort 2 are reported in Supplementary Table 2. INS-t1/2, terminal half-life of serum INS; R, reference; T, treatment.

  • * Mean ± SD.

  • Median (interquartile range).

  • 1 of 18 subjects with INS <LLOQ.

  • § One withdrawal prior to period 2.

  • ǁ INS-Cmaxss INS-C24ss.

  • (INS-Cmaxss − INS-C24ss)/INS-C24ss.