title: Insulin degludec: pharmacokinetics in patients with renal impairment.
abstract: BACKGROUND
  Insulin degludec is a new-generation basal insulin with an ultra-long duration of action. We evaluated the pharmacokinetic properties of insulin degludec in subjects with normal renal function; mild, moderate or severe renal impairment; or end-stage renal disease (ESRD) undergoing hemodialysis.
  
  
  METHODS
  Thirty subjects (n = 6 per group) received a single subcutaneous dose of 0.4 U/kg insulin degludec. Blood samples up to 120 h post-dose and fractionated urine samples were collected.
  
  
  RESULTS
  The ultra-long pharmacokinetic properties of insulin degludec were preserved in subjects with renal impairment, with no statistically significant differences in absorption or clearance, compared with subjects with normal renal function. In subjects with ESRD, pharmacokinetic parameters were similar whether the insulin degludec pharmacokinetic assessment period included hemodialysis or not, and total exposure was comparable to subjects with normal renal function. Simulated mean steady-state pharmacokinetic profiles were comparable between groups.
  
  
  CONCLUSIONS
  This study indicated dose adjustments due to impaired renal function should not be required for insulin degludec.
authors.affiliation: Division of Clinical Pharmacology, Department of Nephrology-Hypertension, St Imre Teaching Hospital, Tetenyi Str. 12-16, Budapest, 1115, Hungary, ikiss@enternet.hu.
authors.forename: István
authors.initials: I
authors.lastname: Kiss
authors.forename: Gerhard
authors.initials: G
authors.lastname: Arold
authors.forename: Carsten
authors.initials: C
authors.lastname: Roepstorff
authors.forename: Susanne Gammelgaard
authors.initials: SG
authors.lastname: Bøttcher
authors.forename: Søren
authors.initials: S
authors.lastname: Klim
authors.forename: Hanne
authors.initials: H
authors.lastname: Haahr
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000378:metabolism; D015314:Dialysis Solutions / Q000032:analysis; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D049528:Insulin, Long-Acting / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D007668:Kidney / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000378:metabolism*
chemical_list: D015314:Dialysis Solutions; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; C571886:insulin degludec