Table 2

PD 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)
n1817
GIR-AUC0–24, mg·kg−1*2,449 (1,172)2,028 (1,223)0.73 (0.56 to 0.94)
GIR-AUC0–36, mg·kg−1*2,614 (1,182)2,432 (1,379)0.85 (0.70 to 1.03)
GIRmax, mg·kg−1·min−13.2 (2.6–3.8)2.5 (1.8–3.4)0.81 (0.68 to 0.97)
T50%-GIR-AUC0–24, h10.2 (9–11)11.2 (10–13)0.86 (−0.75 to 2.76)
T50%-GIR-AUC0–36, h11.0 (9–12)14.4 (11–16)2.49 (1.05 to 4.77)
  • GIRmax is the maximum smoothed body-weight–standardized GIR (LOESS factor of 0.06). 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 3. R, reference; T, treatment.

  • * Mean (SD).

  • Median (interquartile range).

  • One withdrawal prior to period 2.