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Authors
Novodvorský, Peter https://orcid.org/0000-0002-3292-7586
Thieme, Lenka
Laňková, Ivana
Mráz, Miloš
Taybani, Zoltán J.
Bótyik, Balázs
Stella, Péter
Vytasil, Miroslav
Lauand, Felipe
Bonnemaire, Mireille
Haluzík, Martin https://orcid.org/0000-0002-0201-6888
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04945070 at ClinicalTrials.govDocuments that mention this clinical trial
The IDEAL (Insulin therapy DE-intensificAtion with iglarLixi) Randomised Controlled Trial—Study Design and Protocol
https://doi.org/10.1007/s13300-024-01582-x
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Funding
Funding for this research was provided by:
Sanofi (This is an investigator-initiated study which is supported by Sanofi.)
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Article History
Received: 8 March 2024
Accepted: 2 April 2024
First Online: 24 April 2024
Declarations
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: Peter Novodvorsky has served on speaker panels for Novo Nordisk, Eli Lilly, Sanofi, Boehringer-Ingelheim, Mundipharma, Krka, Viatris, Novartis, Abbott and Medtronic; on advisory panels for Sanofi and Boehringer-Ingelheim; received honoraria or consulting fees from Merck and Eli Lilly; and received travel grants from Sanofi, Novo Nordisk, Berlin Chemie, Boehringer-Ingelheim and Eli Lilly. Zoltán J. Taybani received honoraria for speaking at meetings from Novo Nordisk, Sanofi, Eli Lilly, AstraZeneca, Boehringer Ingelheim and Novartis, Balázs Bótyik received honoraria for speaking at meetings from Novo Nordisk, Sanofi, Eli Lilly, AstraZeneca, Boehringer Ingelheim and Novartis, Martin Haluzik has served on advisory panel for Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma; and has served as a consultant for Eli Lilly, Novo Nordisk, Sanofi, Astra Zeneca, Mundipharma; and has received research support for AstraZeneca, Eli Lilly, Bristol-Meyers Squibb; and has received honoraria or consulting fees from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Johnson. Felipe Lauand, Mireille Bonnemaire and Miroslav Vytasil are employees and shareholders of Sanofi. All other authors of this work have no relevant conflict of interest to disclose.
: Prior to enrollment, the protocol was reviewed and approved by the Joint Ethics Committee of the Institute for Clinical and Experimental Medicine and Thomayer Hospital in Prague, Czech Republic, and this approval is valid for all study sites. This study will be conducted in accordance with the Helsinki Declaration of 1964 and its later amendments and the ICH Good Clinical Practice Guidelines. All participants will be asked to provide written informed consent to participate in the study.
