Table 1

PK/PD parameters

Study
ParameterR+R- horizontalR- upR- downP value
PK
 FIRI_AUC(0–end of study) (μU/mL · h−1) (*P < 0.05 vs. R+, R- horizontal, R- up; §P < 0.05 vs. R+)248 ± 88206 ± 41§188 ± 35§323 ± 52*0.001
 FIRI Cmax (μU/mL) (*Cmax P < 0.05 vs. R- horizontal, R- up)24 ± 9.3*19 ± 3.517 ± 2.927 ± 3.1*0.001
 FIRI Tmax (h)4.7 ± 0.63.6 ± 2.24.6 ± 1.64.7 ± 0.60.143
PD
 AUC plasma glucose (mg/dL · h−1) (*P < 0.05 vs. R- up)171 ± 61205 ± 55208 ± 53164 ± 44*0.049
 Plasma glucose Tmax (h) (*P < 0.05 vs. R+, R- horizontal, R- up; §P < 0.05 vs. R+)17.3 ± 2.616.5 ± 1.815.4 ± 2.2§19.7 ± 2.2*0.001
 Onset of action (h) (*P < 0.05 vs. R+)2.2 ± 1.21.7 ± 1.21.7 ± 11 ± 0*0.008
 End of action (h) (*P < 0.05 vs. R+, R- horizontal, R- up)13.9 ± 2.311.9 ± 2.111.1 ± 2.116.4 ± 2.3*0.001
 Duration of action (h) (*P < 0.05 vs. R+, R- horizontal, R- up; §P < 0.05 vs. R+)11.8 ± 2.610.1 ± 1.89.4 ± 1.7§15.4 ± 2.3*0.001
GIR
 Cmax (mg/kg/min) (*P < 0.05 vs. R- horizontal, R- up; §P < 0.05 vs. R+)3.8 ± 2.82.6 ± 1.71.7 ± 1.2§5.1 ± 3.0*0.001
 Tmax (h)6.2 ± 1.46.3 ± 1.25.4 ± 0.95.1 ± 0.70.206
 AUC0–end of study (mg/kg) (*P < 0.05 vs. R+, R- horizontal, R- up; §P < 0.05 vs. R+)1,342 ± 1,129774 ± 637481 ± 322§1,957 ± 1,253*0.001
  • Data are mean ± SD. Boldface indicates significance at P < 0.05.

  • †See research design and methods for definition.