Population Pharmacokinetics of Semaglutide for Type 2 Diabetes
| Autor: | Steen H. Ingwersen, Kristin C. Carlsson Petri, Thomas W. Anderson, Rune Viig Overgaard, Anne Flint, Philip Harder Delff |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Endocrinology
Diabetes and Metabolism Population 030209 endocrinology & metabolism Type 2 diabetes 030204 cardiovascular system & hematology Pharmacology law.invention 03 medical and health sciences 0302 clinical medicine Clinical trials Pharmacokinetics law Diabetes mellitus Internal Medicine medicine Distribution (pharmacology) education Original Research education.field_of_study Population analysis Clinical pharmacology business.industry Semaglutide Diabetes medicine.disease Pharmacotherapy Clinical trial business |
| Zdroj: | Diabetes Therapy |
| ISSN: | 1869-6961 1869-6953 |
| Popis: | Introduction The aim of the present analysis was to characterise the absorption, distribution and elimination of semaglutide by means of population pharmacokinetic (PK) models using data from nine clinical pharmacology trials conducted in both healthy subjects and those with type 2 diabetes. Methods Data were obtained from trials with subcutaneous and intravenous administration of semaglutide that utilised frequent PK sampling and included a total of 353 subjects with 10,573 concentration values. Results Semaglutide PK properties across trials, drug product strengths and populations were well characterised by a two-compartment model with first-order absorption and elimination. For a typical subject with type 2 diabetes, clearance was estimated to be 0.0348 L/h [95% confidence interval (CI) 0.0327–0.0369 L/h], and the central and peripheral volumes were estimated to be 3.59 L (95% CI 3.28–3.90 L) and 4.10 L (95% CI 3.78–4.42 L), respectively (i.e. a total volume of distribution of 7.7 L). Interindividual variation was low (~ 15%) for both clearance and volumes of distribution, with low residual error ( |
| Databáze: | OpenAIRE |
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