Table 3.
Relationship between degree of renal or hepatic impairment and insulin degludec pharmacokinetic parameters [adapted from Kupčová et al. [27] (Table 2, p. 131) and Kiss et al. [28] (Table 4, p. 180), with kind permission from Springer Science + Business Media)
| Comparison of grades of renal/hepatic impairment | Renal impairment study [28] | Hepatic impairment study [27] | ||
|---|---|---|---|---|
| AUCIDeg,0–∞ | C max,IDeg | AUCIDeg,0–120h | C max,IDeg | |
| Mild vs. normal | 1.11 (0.80–1.54) | 1.14 (0.81–1.61) | 0.95 (0.77–1.16) | 0.90 (0.67–1.20) |
| Moderate vs. normal | 1.11 (0.80–1.53) | 1.06 (0.76–1.49) | 1.00 (0.82–1.22) | 0.77 (0.58–1.03) |
| Severe vs. normal | 1.19 (0.86–1.65) | 1.23 (0.87–1.73) | 0.92 (0.74–1.14) | 0.75 (0.55–1.02) |
| ESRD vs. normal | 1.02 (0.74–1.40) | 1.05 (0.75–1.46) | N/A | N/A |
Data are expressed as ratio (90 % confidence interval)
Pair-wise comparisons are shown for subjects with impaired renal function and those with normal renal function after a single dose of IDeg. Data in ESRD groups are based on pharmacokinetic profiles (excluding a haemodialysis session) [28]. For the data from the hepatic impairment study, the endpoints were log-transformed and analysed using an analysis of variance model with hepatic function group, sex and age at baseline as fixed effects [27]
AUC area under the plasma concentration–time curve, C max maximum concentration, ESRD end-stage renal disease, IDeg insulin degludec, N/A not applicable