Table 1—

PK and GD results following administration of HIIP or SC insulin lispro

HIIP
SC lispro
2.6 mg5.2 mg7.8 mg6 units12 units18 units
PK parameters
    PK predicted HIIP dose (mg) (95% CI)3.4 (2.6–4.4)5.3 (4.3–6.6)6.9 (5.5–9.0)
    AUC(0-t′) (pmol · min−1 · l−1)28,500 (42.8)59,000 (51.1)105,000 (46.8)37,100 (25.2)65,800 (33.2)78,700 (39.3)
    Cmax (pmol/l)161 (50.3)287 (58.3)512 (60.1)311 (22.4)414 (34.6)523 (43.3)
    NPK12311383212
    tmax (min)45 (10–120)30 (10–120)45 (20–120)45 (30–90)45 (20–180)45 (30–90)
    Percent F7.35 (62.8)7.39 (61.9)8.90 (58.5)
GD parameters
    GD predicted HIIP dose (mg) (95% CI)2.6 (1.8–3.6)5.0 (3.8–6.7)7.4 (5.6–10.5)
    Gtot (0–600) (mg)87,200 (48.5)137,000 (37.1)175,000 (40.6)82,500 (42.4)132,000 (35.3)161,000 (29.8)
    Rmax (mg/min)*267 (55.7)425 (38.1)499 (34.1)423 (44.3)563 (37.8)672 (34.6)
    NGD123113123214
    tRmax (min)*260 (44–489)191 (65–315)211 (66–374)85 (63–188)112 (64–211)136 (84–211)
    tonset (min)13 (20–31)13 (2–34)15 (4–27)24 (2–29)16 (4–33)22 (7–41)
    Early t50% (min)*§40 (10–185)43 (21–139)33 (16–139)35 (25–55)38 (15–53)38 (27–61)
    Late t50% (min)*458 (252–575)371 (242–568)404 (280–592)184 (125–308)248 (158–326)273 (199–360)
    Percent F′9.74 (52.1)8.28 (47.4)8.32 (43.0)
  • Data are geometric mean (% CV) and median (range) unless otherwise indicated.

  • *

    * Observed from Loess smoothed data;

  • P < 0.001 for HIIP vs. SC lispro;

  • P = 0.005 for HIIP vs. SC lispro;

  • §

    § P = 0.013 for HIIP vs. SC lispro;

  • P < 0.001 for HIIP vs. SC lispro. F, relative bioavailability; F′, relative biopotency.