Population Pharmacokinetics of Semaglutide for Type 2 Diabetes

Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders
Rune Viig OvergaardSteen Hvass Ingwersen

Abstract

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. 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. 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 (< 5%). Clearance and the total volume of distribution were approximately proportional to body weight. Minor differences were identified between healthy subjec...Continue Reading

References

Dec 17, 2011·Journal of Clinical Pharmacology·Steen H IngwersenChristoffer W Tornøe
May 31, 2013·Clinical Pharmacokinetics·Lei Diao, Bernd Meibohm
Aug 27, 2015·Journal of Medicinal Chemistry·Jesper LauThomas Kruse
Oct 21, 2016·Clinical Pharmacokinetics·Rune V OvergaardChristine B Jensen
Sep 22, 2016·British Journal of Clinical Pharmacology·Brenda Cirincione, Donald E Mager
Mar 23, 2017·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Lene JensenMette Lund Pedersen
Dec 6, 2017·Diabetes, Obesity & Metabolism·Lene JensenJulie B Hjerpsted
May 12, 2018·Diabetes, Obesity & Metabolism·Kristin C C PetriRune V Overgaard
May 26, 2018·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Valentin DemmelAnne Flint
Jun 17, 2018·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Kristin Cecilie Carlsson PetriRune Viig Overgaard

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Citations

Feb 5, 2021·International Journal of Pharmaceutics·Noura G EissaAyat Allam
May 11, 2021·Clinical Pharmacokinetics·Rune V OvergaardRasmus Juul Kildemoes

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Clinical Trials Mentioned

NCT02146079
NCT02212067
NCT02210871
NCT02064348
NCT02147431
NCT02079870
NCT02231684
NCT02022254
NCT02243098

Software Mentioned

NONMEM
R

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