Table 4.
Comparison of exenatide clearance and dose–weight normalized AUC0–∞ and Cmax between each renal impairment group (mild, moderate and ESRD) and the healthy control group
| Renal function group | n | LS geometric mean | LS geometric mean ratio renal group/healthy (90% CI) | P-value | |
|---|---|---|---|---|---|
| AUC0–∞ (pg h ml−1)/(µg kg−1) | Healthy | 8 | 19 917 | – | |
| Mild RI | 8 | 16 036 | 0.81 (0.66, 0.98) | 0.066 | |
| Moderate RI* | 6 | 19 258 | 0.97 (0.77, 1.21) | 0.801 | |
| ESRD | 8 | 67 102 | 3.37 (2.80, 4.06) | <0.001 | |
| Cmax (pg ml−1)/(µg kg−1) | Healthy | 8 | 5 392 | – | |
| Mild RI | 8 | 3 650 | 0.68 (0.49, 0.93) | 0.047 | |
| Moderate RI* | 6 | 3 507 | 0.65 (0.45, 0.94) | 0.060 | |
| ESRD | 8 | 7 434 | 1.38 (1.01, 1.88) | 0.088 | |
| CLp/F (l h−1) | Healthy | 8 | 3.64 | – | – |
| Mild RI | 8 | 4.72 | 1.30 (1.02, 1.66) | 0.08 | |
| Moderate RIa | 6 | 4.07 | 1.12 (0.84, 1.49) | 0.52 | |
| ESRD | 8 | 0.94 | 0.26 (0.20, 0.33) | ≤0.001 |
*
One subject receiving 10 µg was excluded as an outlier due to atypically low concentrations. ESRD, End-stage renal disease; RI, renal impairment.