Colhoun, Helen M.
Leiter, Lawrence A.
Müller-Wieland, Dirk
Cariou, Bertrand
Ray, Kausik K.
Tinahones, Francisco J.
Domenger, Catherine
Letierce, Alexia
Israel, Marc
Samuel, Rita
Del Prato, Stefano
Clinical trials referenced in this document:
Documents that mention this clinical trial
Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk
https://doi.org/10.1186/s12933-017-0552-4
Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol
https://doi.org/10.1186/s12933-020-0991-1
Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies
https://doi.org/10.1186/s12933-019-0951-9
Funding for this research was provided by:
Sanofi
Regeneron Pharmaceuticals
Article History
Received: 7 November 2019
Accepted: 22 January 2020
First Online: 8 February 2020
Ethics approval and consent to participate
: The ODYSSEY DM-DYSLIPIDEMIA clinical trial was conducted in accordance with the ethical principles laid down by the 18th World Medical Assembly (Helsinki, 1964) and all applicable amendments laid down by the World Medical Assemblies, and the International Conference on Harmonization guidelines. The trial protocol was approved by the relevant institutional review boards or independent ethics committees, and all participating individuals provided written informed consent.
: Not applicable.
: HMC has received speaker’s bureau and consultant/advisory board fees from Sanofi Aventis, Regeneron Pharmaceuticals, Inc., Novartis Pharmaceuticals, Novo-Nordisk, and Eli Lilly; has received non-binding research support from Pfizer Inc., AstraZeneca LP, and Novo-Nordisk; and is a shareholder of Roche Pharmaceuticals and Bayer. LAL has received grants and personal fees from Amgen, AstraZeneca, Eli Lilly and Company, Esperion, HLS, Merck, Regeneron Pharmaceuticals, Inc., and Sanofi; and grants from Kowa and the Medicines Company. DM-W has received consultant fees/honoraria from Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Corporation, Novo Nordisk Inc., and Sanofi-Aventis; and participated in speaker’s bureau for Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis Corporation, Novo Nordisk Inc., and Sanofi-Aventis. BC has received research funding and personal fees from Sanofi and Regeneron Pharmaceuticals, Inc.; research funding from Amgen and Pfizer; and honoraria from Amgen, Akcea, AstraZeneca, Pierre Fabre, Genfit, Gilead, Eli Lilly and Company, MSD (Merck & Co.), Novo Nordisk, Sanofi, and Servier. KKR has received research grants from Pfizer Inc., Amgen, Sanofi, Regeneron Pharmaceuticals, Inc., and MSD; honoraria from Dr Reddy’s Laboratories, Zuellig Pharma, Sanofi, Amgen, Boehringer Ingelheim, Novo Nordisk, and Pfizer Inc.; and consultant/advisory board fees from Medco, AstraZeneca, Resverlogix, Kowa, Abbvie, Sanofi, Amgen, Boehringer Ingelheim, Esperion, Akcea, and Regeneron Pharmaceuticals, Inc. FJT has received speaker’s bureau and consultant/advisory board fees from AstraZeneca, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceuticals, MSD (Merck & Co.), Novartis Pharmaceuticals Co., Novo Nordisk, and Sanofi-Aventis. CD and AL are employees of and stockholders in Sanofi. MKI and RS are employees of and stockholders in Regeneron Pharmaceuticals, Inc. SDP has received research funding from AstraZeneca, Boehringer Ingelheim, Novartis Pharmaceuticals Co., and MSD (Merck & Co.); and has been a consultant for or received honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceuticals, Laboratoires Servier, MSD (Merck & Co.), Novartis Pharmaceuticals Co., Novo Nordisk, Sanofi-Aventis, and Takeda Pharmaceuticals.