A Review of the Dose Justification of Phase 3 Trials to Regulatory Authorities for Drugs Intended for the Treatment of Type 2 Diabetes in Europe

A Review of the Dose Justification of Phase 3 Trials to Regulatory Authorities for Drugs Intended for the Treatment of Type 2 Diabetes in Europe

Aims: Cardiovascular outcome trials with anti-diabetic drugs suggest that additional cardiovascular benefit can be achieved independent of improving glycaemic control. Nonetheless, dose selection of anti-diabetic drugs is typically based solely on glycaemic effects. We evaluated whether off-target d...

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Bibliographic Details
Main Authors: Jeroen V. Koomen, Jasper Stevens, Margje H. Monster-Simons, Hiddo J. L. Heerspink, Peter G. M. Mol
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-04-01
Series:Frontiers in Pharmacology
Subjects:
Type 2 diabetes
Dose-finding
dose-response relationship
Dose selection
regulatory evaluation
cardiovascular outcome trials
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2021.626766/full

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