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Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes.
Pieber, Thomas R; Asong, Marisse; Fluhr, Gabriele; Höller, Vera; Kristensen, Niels R; Larsen, Jonas H; Ribel-Madsen, Rasmus; Svehlikova, Eva; Vinther, Siri; Voortman, Margarete; Haahr, Hanne.
Afiliación
  • Pieber TR; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.
  • Asong M; Novo Nordisk, Søborg, Denmark.
  • Fluhr G; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.
  • Höller V; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.
  • Kristensen NR; Novo Nordisk, Søborg, Denmark.
  • Larsen JH; Novo Nordisk, Aalborg, Denmark.
  • Ribel-Madsen R; Novo Nordisk, Søborg, Denmark.
  • Svehlikova E; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.
  • Vinther S; Novo Nordisk, Søborg, Denmark.
  • Voortman M; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.
  • Haahr H; Novo Nordisk, Søborg, Denmark.
Diabetes Obes Metab ; 25(12): 3716-3723, 2023 12.
Article en En | MEDLINE | ID: mdl-37694740
AIMS: To characterize the pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in type 2 diabetes (T2D). MATERIALS AND METHODS: In an open-label trial, 46 individuals with T2D (18-75 years; body mass index 18.0-38.0 kg/m2 ; glycated haemoglobin ≤75 mmol/mol [≤9%]; basal insulin-treated) received subcutaneous once-weekly icodec for ≥8 weeks at individualized doses, aiming at a pre-breakfast plasma glucose concentration of 4.4 to 7.0 mmol/L (80-126 mg/dL) on the last three mornings of each weekly dosing interval. Frequent blood sampling to assess total serum icodec concentration (ie, albumin-bound and unbound) occurred from first icodec dose until 35 days after last dose. Icodec trough concentrations following initiation of once-weekly dosing were predicted by pharmacokinetic modelling. During the final 3 weeks of icodec treatment, while at steady state, the icodec glucose-lowering effect was assessed in three glucose clamps (target 7.5 mmol/L [135 mg/dL]): 0 to 36, 40 to 64 and 144 to 168 h post-dose, thus covering the initial, middle and last part of the 1-week dosing interval. Glucose-lowering effect during a complete dosing interval was predicted by pharmacokinetic-pharmacodynamic modelling. RESULTS: Model-predicted icodec steady state was attained after 3 to 4 weeks. At steady state, model-predicted daily proportions of glucose-lowering effect on days 1 to 7 of the 1-week dosing interval were 14.1%, 16.1%, 15.8%, 15.0%, 14.0%, 13.0% and 12.0%, respectively. Icodec duration of action was at least 1 week in all participants. Once-weekly icodec was overall safe and well tolerated in the current trial. CONCLUSIONS: The pharmacokinetic and pharmacodynamic characteristics of icodec in individuals with T2D support its potential as a once-weekly basal insulin.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Prognostic_studies Límite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2023 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 2 Tipo de estudio: Prognostic_studies Límite: Adolescent / Adult / Aged / Humans / Middle aged Idioma: En Revista: Diabetes Obes Metab Asunto de la revista: ENDOCRINOLOGIA / METABOLISMO Año: 2023 Tipo del documento: Article País de afiliación: Austria Pais de publicación: Reino Unido