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Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog® (Lispro) in Patients with Type 2 Diabetes Mellitus: A Phase I Randomised, Crossover Study.
Leohr, Jennifer; Dellva, Mary Anne; Coutant, David E; LaBell, Elizabeth; Heise, Tim; Andersen, Grit; Zijlstra, Eric; Hermanski, Lidia; Nosek, Leszek; Linnebjerg, Helle.
Afiliación
  • Leohr J; Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA. leohr_jennifer_k@lilly.com.
  • Dellva MA; Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.
  • Coutant DE; Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.
  • LaBell E; Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.
  • Heise T; Profil, Neuss, Germany.
  • Andersen G; Profil, Neuss, Germany.
  • Zijlstra E; Profil, Neuss, Germany.
  • Hermanski L; Profil, Neuss, Germany.
  • Nosek L; Profil, Neuss, Germany.
  • Linnebjerg H; Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.
Clin Pharmacokinet ; 59(12): 1601-1610, 2020 12.
Article en En | MEDLINE | ID: mdl-32468448
BACKGROUND AND OBJECTIVE: 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 insulin lispro pharmacokinetics and glucodynamics, safety and tolerability of URLi and Humalog® after a single subcutaneous dose in patients with type 2 diabetes mellitus (T2DM). METHODS: This was a phase I, randomised, two-period, two-treatment, double-blind, crossover study in 38 patients with T2DM. At each dosing visit, patients received either 15 units of URLi or Humalog, followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured. RESULTS: Insulin lispro appeared in the serum 5 min faster (p < 0.0001) and exposure was 6.4-fold greater in the first 15 min (p < 0.0001) with URLi versus Humalog. Exposure beyond 3 h postdose was 26% lower and the duration of exposure was 51 min shorter with URLi versus Humalog. Onset of insulin action was 13 min faster (p < 0.0001) and insulin action was 4.2-fold greater within the first 30 min (p < 0.0001) with URLi versus Humalog. Insulin action beyond 4 h postdose was 20% lower (p = 0.0099) with URLi versus Humalog. Overall insulin lispro exposure and total glucose infused were similar for URLi and Humalog. Both treatments were well tolerated. CONCLUSIONS: This is the first study to investigate URLi in patients with T2DM using a euglycaemic clamp procedure. URLi demonstrated ultra-rapid pharmacokinetics and glucodynamics in patients with T2DM. CLINICALTRIALS. GOV IDENTIFIER: NCT03305822.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 / 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 2 / 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