A single-dose pharmacokinetic study of basal insulin peglispro (BIL) in subjects with hepatic impairment
SL Choi, C Loghin, P Garhyan, MP Knadler, E Lam, V Sinha, N Porksen, H Linnebjerg · Diabetologie und Stoffwechsel · 2015 · Heft 04
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Zusammenfassung
Introduction: BIL is a novel, PEGylated basal insulin lispro with large hydrodynamic size. It has a prolonged duration of action. LY2605541 pharmacokinetics (PK) were compared in subjects with varying degrees of hepatic impairment (HI) and healthy subjects. Methods: In this parallel-group, open-label study, 35 subjects received a single 0.33U/kg subcutaneous dose of BIL. Serum was obtained for up to 9 days postdose and analysed using ELISA. BIL PK parameters were calculated using noncompartmental analyses and compared between healthy and HI subjects. Results: 35 subjects were assessed (12 healthy; 8 mild, 8 mode…