Table 1.
Pharmacokinetic parameters | Unit | Differences between insulin formulations | Average of within-subject standard deviation (SD) | Difference (95% Confidence Interval) | ||||
---|---|---|---|---|---|---|---|---|
p-value | Means | p-value | RHI SD | UFI SD | ||||
RHI | UFI | |||||||
Cmax | (mU/liter) | 0.0086 | 23.7 | 32.7 | 0.6240 | 10.0 | 7.6 | 2.4 (−7.9 to 12.7) |
tCmax | (min) | <0.0001 | 97 | 33 | 0.0270 | 39 | 16 | 24 (3 to 45) |
tCmax+50% | (min) | <0.0001 | 32 | 8 | 0.0229 | 20 | 6 | 14 (2 to 25) |
tCmax−50% | (min) | <0.0001 | 215 | 131 | 0.0845 | 65 | 35 | 30 (−5 to 65) |
AUCINS 0-180 | (mU/liter*min) | <0.0001 | 2552 | 3442 | 0.7647 | 665 | 626 | 38 (−232 to 309) |
AUCINS 0–480 | (mU/liter*min) | 0.9612 | 4410 | 4395 | 0.5308 | 916 | 823 | 94 (−220 to 407) |
Pharmacodynamic parameters | ||||||||
GIRmax | (mg/kg/min) | <0.0001 | 4.1 | 5.6 | 0.4745 | 1.3 | 1.5 | −0.2 (−0.9 to 0.4) |
tGIRmax | (min) | 0.0015 | 154 | 99 | 0.0221 | 74 | 36 | 38 (6 to 69) |
tGIRmax+50% | (min) | 0.1317 | 51 | 38 | 0.0601 | 32 | 17 | 15 (−1 to 31) |
tGIRmax−50% | (min) | 0.0062 | 165 | 119 | 0.0759 | 72 | 39 | 33 (−4 to 70) |
AUCGIR 0-180 | (mg/kg) | <0.0001 | 276 | 458 | 0.3804 | 89 | 112 | −23 (−79 to 32) |
AUCGIR 0-480 | (mg/kg) | 0.2197 | 592 | 647 | 0.2889 | 199 | 151 | 47 (−45 to 140) |
AUCGIR 180-480 | (mg/kg) | 0.0001 | 311 | 193 | 0.0182 | 135 | 67 | 68 (14 to 123) |
Values in bold indicate significant changes in variability.