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Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog® (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial.
Linnebjerg, Helle; Zhang, Qianyi; LaBell, Elizabeth; Dellva, Mary Anne; Coutant, David E; Hövelmann, Ulrike; Plum-Mörschel, Leona; Herbrand, Theresa; Leohr, Jennifer.
Afiliación
  • Linnebjerg H; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. linnebjerg_helle@lilly.com.
  • Zhang Q; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
  • LaBell E; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
  • Dellva MA; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
  • Coutant DE; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
  • Hövelmann U; Profil, Neuss, Germany.
  • Plum-Mörschel L; Profil, Mainz, Germany.
  • Herbrand T; Profil, Neuss, Germany.
  • Leohr J; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Clin Pharmacokinet ; 59(12): 1589-1599, 2020 12.
Article en En | MEDLINE | ID: mdl-32468447
BACKGROUND: Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetics, glucodynamics, safety, and tolerability of URLi and Humalog® in patients with type 1 diabetes mellitus (T1DM). METHODS: This was a phase I, two-period, randomised, double-blind, crossover glucose clamp study in younger adult (aged 18-45 years; n = 41) and elderly (aged ≥65 years; n = 39) patients with T1DM. At each dosing visit, patients received either URLi or Humalog (15 units subcutaneously) followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured. RESULTS: Insulin lispro appeared in serum 6 min faster, and exposure was 7.2-fold greater over the first 15 min postdose with URLi versus Humalog in both age groups. Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups. Onset of insulin action was 11-12 min faster, and insulin action was 3-fold greater over the first 30 min postdose with URLi versus Humalog in both age groups. Insulin action beyond 4 h postdose was 44-54% lower, and duration of action was reduced by 34-44 min with URLi versus Humalog in both age groups. Overall exposure and total insulin action remained similar for both treatments. URLi and Humalog were well tolerated. CONCLUSION: In patients with T1DM, URLi showed ultra-rapid pharmacokinetics and glucodynamics, with the differences between URLi and Humalog in elderly patients mirroring those in younger adults. ClinicalTrials.gov identifier: NCT03166124.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 1 / Insulina Lispro / Hipoglucemiantes Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Pharmacokinet Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 1 / Insulina Lispro / Hipoglucemiantes Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Pharmacokinet Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza