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SHR Neuro Cancer Cardio Lipid Metab Microb

Pieber, TR; Asong, M; Fluhr, G; Holler, V; Kristensen, NR; Larsen, JH; Ribel-Madsen, R; Svehlikova, E; Vinther, S; Voortman, M; Haahr, H.
Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes
DIABETES OBES METAB. 2023; Doi: 10.1111/dom.15266
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Leading authors Med Uni Graz

Pieber Thomas

Co-authors Med Uni Graz

Fluhr Gabriele

Höller Vera

Svehlikova Eva

Voortman Margarete Maria

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Abstract:

AimsTo characterize the pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in type 2 diabetes (T2D).Materials and MethodsIn an open-label trial, 46 individuals with T2D (18-75 years; body mass index 18.0-38.0 kg/m(2); 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.ResultsModel-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.ConclusionsThe pharmacokinetic and pharmacodynamic characteristics of icodec in individuals with T2D support its potential as a once-weekly basal insulin.

Find related publications in this database (Keywords)

basal insulin

clinical trial

pharmacodynamics

pharmacokinetics

type 2 diabetes

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