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AimsTo assess the effects of body mass index, renal impairment (creatinine clearance), and hepatic impairment (Child-Pugh Score) on the pharmacokinetics of insulin aspar t. MethodsPharmacokinetics of insulin aspart (injected subcutaneously in the abdomen immediately before a Boost ® standardized meal) were characterized in: (1) diabetic subjects with four ranges of BMI values ( n = 23); (2) diabetic subjects with varying degrees of renal impairment (normal, n = 6 vs. two ranges of impairment, n = 12); and (3) nondiabetic patients with varying degrees of hepatic impairment (normal, n = 6 vs. three ranges of impairment, n = 18). ResultsThere was no correlation between any pharmacokinetic variable and the deg ree of renal or hepatic impairment. Increasing obesity was associated with a decreased apparent clearance per kg body weight ( b = -0.0005, SE = 0.0001; P = 0.002), an increased t 1 / 2 ( b = 3.513, SE = 1.636; P = 0.044), and an increased ln(AUC 0 -360 ) and ln(AUC 0 -1440 ) ( b = 0.030, SE = 0.013; P = 0.032 and b = 0.039, SE = 0.0132; P = 0.006, respectively). However, obesity-related changes were smaller than individual variations in parameters. ConclusionsRenal impairment, hepatic impairment, or BMI do not affect the pharmacokinetics of insulin aspart in a clinically significant manner.

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