Population Pharmacokinetic And Exposure-Response Analysis Of Linagliptin In Pediatric Patients With Type 2 Diabetes Mellitus.pdf

ACoP14_M-035_Population-Pharmacokinetic-and-Exposure-Response-Analysis-of-Linagliptin-in-Pediatric-Patients-with-Type-2-Diabetes-Mellitus.pdf
Preview of Population Pharmacokinetic and Exposure-Response Analysis of Linagliptin in Pediatric Patients with Type 2 Diabetes Mellitus
🔗 Source: metrumrg.com
📊 Size: 330 KB
📄 Pages: 1 page
⬇️ Downloads: 53

Summary

Linagliptin, a DPP-4 inhibitor, was evaluated in pediatric patients with type 2 diabetes mellitus (T2DM) in a 26-week trial with a 52-week safety extension. Population pharmacokinetic (PK) and exposure-response (ER) models were developed using Bayesian methods, incorporating prior knowledge from adult studies. Pediatric patients achieved slightly larger but more variable linagliptin exposures and a smaller, more variable placebo-adjusted HbA1c decrease compared to adults. The PK model was a two-compartment model with first-order absorption and saturable binding, while the ER model was a turnover model with time-varying disease progression and maximal inhibition. Simulations showed pediatric patients had 19.9% higher AUCss values and a smaller median placebo-adjusted HbA1c decrease at week 26 (-0.41% vs -0.61%) compared to adults.

Description

Linagliptin, a DPP-4 inhibitor, was evaluated in pediatric patients with type 2 diabetes mellitus (T2DM) in a 26-week trial with a 52-week safety extension.

Technical Information

  • File Format: PDF
  • File Size: 330 KB
  • Pages: 1
  • Language: EN
  • Total Downloads: 53
  • Last Updated: 2 days ago

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