The VERIFY study, the development of this article, and the journal’s Rapid Service Fees, were funded by Novartis, Basel, Switzerland.
Medical Writing Assistance
Medical writing support, under the direction of the authors, was provided by Caroline Shepherd, BPharm, CMC Connect, McCann Health Medical Communications, and Eleanor Finn, PhD, on behalf of CMC Connect, McCann Health Medical Communications, funded by Novartis, Basel, Switzerland, in accordance with Good Publication Practice (GPP3) guidelines.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
David Matthews has served on advisory panels for Novo Nordisk and Servier; he has acted as Co-Chair of the CANVAS trial funded by Janssen, and Chair of VERIFY trial funded by Novartis. He has served as a steering committee member of FOCUS trial funded by Novo Nordisk. Stefano Del Prato has served on advisory panels for AstraZeneca, Boehringer Ingelheim, Eli Lilly & Co, GlaxoSmithKline; Merck & Co., Novartis Pharmaceuticals; Novo Nordisk, Sanofi, Laboratoires Servier, Takeda Pharmaceuticals. He has received research support from AstraZeneca, Boehringer Ingelheim, Merck & Co. He has been engaged as a speaker for AstraZeneca, Boehringer Ingelheim, Eli Lilly & Co., Merck & Co., Novartis Pharmaceuticals, Novo Nordisk, Sanofi, Laboratoires Servier, Takeda Pharmaceuticals. Viswanathan Mohan has received research or educational grants and served on advisory panels for Eli Lilly, Johnson & Johnson, Lifescan, Merck, M/s, MSD, Novartis, Novo Nordisk, Sanofi Aventis, USV and from several Indian pharmaceutical companies. Chantal Mathieu serves or has served on advisory panels for Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Co., Novartis, AstraZeneca, Boehringer Ingelheim, Hanmi Pharmaceuticals, Roche, Medtronic, ActoBio Therapeutics, Pfizer and UCB. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for Chantal Mathieu from Medtronic, Novo Nordisk, Sanofi, Merck Sharp and Dohme Ltd., Eli Lilly and Company, Roche, Abbott, ActoBio Therapeutics and Novartis. Chantal Mathieu serves or has served on the speakers bureau for Novo Nordisk, Sanofi, Merck Sharp and Dohme, Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca and Novartis. Financial compensation for these activities has been received by KU Leuven. Sergio Vencio has received research grants from Novo Nordisk, Biomm, Bayer and Cristalia; and has received honoraria for consultancy or giving lectures from AstraZeneca, Novo Nordisk, Boehringer Ingelheim and Novartis. Juliana Chan has received research grants and/or honoraria for consultancy or giving lectures from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer and Sanofi. Michael Stumvoll has received speaker’s honoraria and consulting fees from Aegerion, AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Novartis and Novo Nordisk. Päivi Maria Paldánius is the medical lead of the VERIFY study and was employed by Novartis at the initial stage of manuscript development. Her current affiliation is Children’s Hospital, Helsinki University Central Hospital and Research Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland. She has served on advisory panels and undertaken speaker engagements for Novartis.
Compliance with Ethics Guidelines
The VERIFY study protocol was approved by the local ethics committees of all study sites and all patients provided written informed consent for participation in the study. The study was designed and carried out in accordance with International Conference on Harmonisation Tripartite Guidelines for Good Clinical Practice and according to the ethical principles of the Declaration of Helsinki, and was overseen by an independent data monitoring committee. The article is a commentary on a previously conducted study previously published that does include human participants. The authors of this commentary were authors of the original manuscript and/or investigators of the study that was previously published.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The criteria and process for trial data availability are described online: https://www.clinicalstudydatarequest.com/