Table 2

Pharmacokinetic and pharmacodynamic parameters after subcutaneous injection of lispro

Healthy subjects (10 units)Subjects with type 2 diabetes (10 units)Subjects with type 2 diabetes (30 units)Subjects with type 2 diabetes (50 units)
ka (min)0.0531 ± 0.02360.0455 ± 0.02420.0184 ± 0.0076§0.0179 ± 0.0091§
Tmax (min)48.3 ± 4.155.7 ± 14.088.6 ± 21.9130. 0 ± 46.0
Cmax (pmol/l)523 ± 42310 ± 28808 ± 2181,313 ± 346#
Cmax/D (liters)0.0091 ± 0.00070.0054 ± 0.00050.0047 ± 0.00120.0046 ± 0.0012
AUC0-∞ (pmol/min/l)68,462 ± 17,34660,683 ± 15,191192,155 ± 46,873372,571 ± 59,578#
AUC0-∞/D (min/l)1.190 ± 0.3021.056 ± 0.2641.140 ± 0.1881.296 ± 0.208
Vz (liters)67 ± 16118 ± 34104 ± 53107 ± 46
Cl (l/min)0.88 ± 0.210.99 ± 0.220.90 ± 0.140.79 ± 0.13
t½ (min)67 ± 15100 ± 3497 ± 38136 ± 72
Mean resistance time (min)119 ± 21180 ± 65196 ± 30236 ± 49
tGIRmax (min)69 ± 12130 ± 23175 ± 21245 ± 64#
GIRmax* (mg/kg/min)9.0 (7.1–11.4)0.6 (0.4–0.9)2.0 (1.4–2.7)2.5 (1.7–3.7)
GItot* (mg/kg)2,299 (1,881–2,811)92 (49–174)364 (249–533)678 (462–994)
  • Data are means ± SD unless otherwise indicated. There were 10 units administered in healthy subjects and 10, 30, and 50 units in obese subjects with type 2 diabetes.

  • *Geometric means with 95% CI;

  • P < 0.001 compared with healthy controls using unpaired t test;

  • P < 0.0001 compared with healthy controls using unpaired t test;

  • §P < 0.04 compared with 10 units in subjects with type 2 diabetes using repeated-measures ANOVA;

  • P ≤0.002 compared with 10 units in subjects with type 2 diabetes using repeated-measures ANOVA;

  • P < 0.05 compared with 30 units in subjects with type 2 diabetes using repeated-measures ANOVA;

  • #P ≤ 0.002 compared with 30 units in subjects with type 2 diabetes using repeated-measures ANOVA.