AIMS: To assess the effects of body mass index, renal impairment (creatinine clearance), and hepatic impairment (Child-Pugh Score) on the pharmacokinetics of insulin aspart. METHODS: Pharmacokinetics 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). RESULTS: There was no correlation between any pharmacokinetic variable and the degree of renal or hepatic impairment. Increasing obesity was associated with a decreased apparent clearance per kg body weight (beta = -0.0005, SE = 0.0001; P = 0.002), an increased t((1/2)) (beta = 3.513, SE = 1.636; P = 0.044), and an increased ln(AUC(0-360)) and ln(AUC(0-1440)) (beta = 0.030, SE = 0.013; P = 0.032 and beta = 0.039, SE = 0.0132; P = 0.006, respectively). However, obesity-related changes were smaller than individual variations in parameters. CONCLUSIONS: Renal impairment, hepatic impairment, or BMI do not affect the pharmacokinetics of insulin aspart in a clinically significant manner.
AIMS: To assess the effects of body mass index, renal impairment (creatinine clearance), and hepatic impairment (Child-Pugh Score) on the pharmacokinetics of insulin aspart. METHODS: Pharmacokinetics 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). RESULTS: There was no correlation between any pharmacokinetic variable and the degree of renal or hepatic impairment. Increasing obesity was associated with a decreased apparent clearance per kg body weight (beta = -0.0005, SE = 0.0001; P = 0.002), an increased t((1/2)) (beta = 3.513, SE = 1.636; P = 0.044), and an increased ln(AUC(0-360)) and ln(AUC(0-1440)) (beta = 0.030, SE = 0.013; P = 0.032 and beta = 0.039, SE = 0.0132; P = 0.006, respectively). However, obesity-related changes were smaller than individual variations in parameters. CONCLUSIONS:Renal impairment, hepatic impairment, or BMI do not affect the pharmacokinetics of insulin aspart in a clinically significant manner.
Authors: P Cavallo-Perin; M Cassader; C Bozzo; A Bruno; P Nuccio; A M Dall'Omo; M Marucci; G Pagano Journal: J Clin Invest Date: 1985-05 Impact factor: 14.808
Authors: Susan S Braithwaite; Hemant Godara; Julie Song; Bruce A Cairns; Samuel W Jones; Guillermo E Umpierrez Journal: J Diabetes Sci Technol Date: 2009-07-01
Authors: Jessica R Castle; Julia M Engle; Joseph El Youssef; Ryan G Massoud; Kevin C J Yuen; Ryland Kagan; W Kenneth Ward Journal: Diabetes Care Date: 2010-03-23 Impact factor: 17.152
Authors: Anna Maria J Thijs; Cees J Tack; Winette T A van der Graaf; Gerard A Rongen; Carla M L van Herpen Journal: Br J Clin Pharmacol Date: 2016-01-14 Impact factor: 4.335
Authors: Peter G Jacobs; Joseph El Youssef; Jessica Castle; Parkash Bakhtiani; Deborah Branigan; Matthew Breen; David Bauer; Nicholas Preiser; Gerald Leonard; Tara Stonex; W Kenneth Ward Journal: IEEE Trans Biomed Eng Date: 2014-05-13 Impact factor: 4.538