Supported by grants from the
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Dr. Doria reports receiving grant support, paid to Joslin Diabetes Center, from Sanofi-Aventis US; Dr. Pop-Busui, receiving grant support, paid to the University of Michigan, from AstraZeneca and consulting fees from Bayer, Boehringer Ingelheim, and Novo Nordisk; Dr. Lingvay, receiving advisory board fees and consulting fees from AstraZeneca, advisory board fees from Boehringer Ingelheim, consulting fees from Eli Lilly, Intarcia Therapeutics, Janssen Global Services, Target Pharma Solutions, and Valeritas Holdings, grant support, paid to her institution, from Mylan Pharmaceuticals and Pfizer, grant support, paid to the University of Texas Southwestern, advisory board fees, consulting fees, and travel support from Novo Nordisk, and advisory board fees from Sanofi US Services; Dr. Rossing, receiving advisory board fees from Astellas Pharma, Boehringer Ingelheim, and Sanofi US Services, advisory board fees and fees for serving on a steering committee from AstraZeneca, Bayer HealthCare, and Novo Nordisk, consulting fees from Eli Lilly, and fees for serving on a steering committee from Gilead Sciences; Dr. Aronson, receiving grant support and consulting fees from AstraZeneca Canada, Becton Dickinson Technologies, Boehringer Ingelheim, Eli Lilly, Janssen Global Services, Novo Nordisk, and Sanofi US Services, grant support from Bausch Health, Bayer, Dexcom, Insulet, Kowa American, Medpace, Tandem Diabetes Care, Xeris Pharmaceuticals, and Zealand Pharma, and consulting fees from Gilead Sciences, HTL-STREFA, and Merck; Dr. Caramori, receiving advisory board fees and presentation fees, paid to her institution, from Bayer; Dr. Crandall, receiving grant support from Abbott Diabetes Care; Dr. de Boer, receiving advisory fees from Boehringer Ingelheim, George Clinical, Goldfinch Bio, and Ironwood Pharmaceuticals; Dr. Goldfine, being employed by Novartis; Dr. Hirsch, receiving consulting fees from Abbott Diabetes Care, Bigfoot Biomedical, and Roche Diabetes Care and grant support, paid to the University of Washington, from Medtronic MiniMed; Dr. Karger, receiving grant support, paid to the University of Minnesota, from Kyowa Kirin and Siemens; Dr. Maahs, receiving consulting fees from Abbott Diabetes Care, grant support, paid to Stanford University, from Dexcom and Tandem Diabetes Care, and advisory board fees from Eli Lilly, Medtronic USA, Novo Nordisk, and Sanofi Pasteur; Dr. Molitch, receiving consulting fees and fees for serving as an expert witness from Janssen Biotech, fees for serving on a data and safety monitoring committee from Merck and Pfizer, and grant support, paid to Northwestern University, from Novartis and Novo Nordisk; Dr. Perkins, receiving consulting fees from Boehringer Ingelheim; Dr. Polsky, receiving grant support from Dexcom, Daisome Pharmaceuticals, Eli Lilly, Lexicon Pharmaceuticals, and Sanofi US Services, and grant support and advisory board fees from Medtronic MiniMed; Dr. Rosas, receiving grant support and advisory board fees from Bayer HealthCare Pharmaceuticals, grant support from Gilead Sciences, Idorsia, Ironwood Pharmaceuticals, and Janssen Pharmaceuticals, and advisory board fees from Reata Pharmaceuticals; Dr. Senior, receiving advisory board fees from Abbott Canada, AstraZeneca Canada, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, Merck, and Sanofi Pasteur, grant support, paid to the University of Alberta, from Allergan, and grant support, paid to the University of Alberta, and advisory board fees from Novo Nordisk; Dr. Tuttle, receiving consulting fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Gilead Sciences, Goldfinch Bio, and Novo Nordisk and honoraria from Bayer; Dr. Wallia, receiving grant support from Novo Nordisk; and Dr. Weinstock, receiving grant support, paid to the Research Foundation of SUNY, from Boehringer Ingelheim, Dexcom, Diasome Pharmaceuticals, Eli Lilly, Insulet, Medtronic MiniMed, Mylan Pharmaceuticals, Oramed Pharmaceuticals, and Tolerion and consulting fees from InsuLogix. No other potential conflict of interest relevant to this article was reported.
Drs. Doria, Galecki, Spino, and Mauer contributed equally to this article.
The views expressed in this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health (NIH), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Aging, JDRF, or GE Healthcare.
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
We thank the patients for participating in this long and demanding trial; the data and safety monitoring board members (Linda Fried, Ananda Basu, Melanie Blank, Tom Greene, Lawrence Holzman, Charity G. Moore Patterson, and John Sedor); NIH officers Teresa Jones, Robert Star, and Michael Flessner and regulatory program specialist Catherine Carr for guidance; the staff of Green Mountain Pharmaceuticals and Belmar Pharmacy (Lakewood, CO) for preparing and distributing allopurinol and placebo; all the research coordinators (Daphne Adelman, Gayatri Anupindi, Cathy Bagne, Mary Bates, Karen Belanger, Emily Boone, Jane Bulger, Leslie Cham, Jing H. Chao, Mary Ann Clearwaters, Mary Jane Clifton, Hector Com, Kristie DeHaan, Tineke Dineen, Amy Dunlop, Sara Eischen, C. Marcelo Falappa, Lestat Feliciano, Birgit Fink, Benjamin Flagg, Victoria Gage, Jason Gensler, Anne Goodling, Monica Hartmuller, Jessie Arman Hermann, Madeleine Hermans, Xinli Huang, Karen Hyams, Marla Inducil, Lone Jelstrup, Florence John, Yvette Kowalski, Vesta Lai, Lee-Ann Langkaas, Diane Larsen, Virginia Leone, Camilla Levister, Dawn Lum, Caroline Lyster, Maria Maione, Elaine Massaro, Jennifer McCance, Christine Mendonca, Sara R. Meyers, Joan Milton, Cindy A. Murphy, Andrej Orszag, Cynthia Plunkett, Carmyn Polk, Laurentiu Pop, Frederik Persson, Danielle Powell, Chinmaya Rajderkar, Clementina Ramos Garrido, Carol Recklein, Marilyn Richardson, Nicole Robinson, Lauri Schafer, Michelle Smith, Anna-Kay Thompson, Lindsey Towers, Josephine Tse, Joanie Tsougrianis, Victoria Tully, Sara Vecchi, Katherine Wilder, Tanisha Wilma, and Brittany Williams); Trudy Strand and Debra Conboy for leading the team of coordinators; Donna DiFranco, Glen Feak, Vasundhara Goplani, Eric Henricks, Lisa Holloway, Navasuja Kumar, Brooke Kilyanek, Ariane Nguyen, and Yi-Miau Tsai for work at the data coordinating center; Theresa Christiansen for serving as the trial pharmacologist; Massimo Pietropaolo for serving as the trial medical monitor; Annie Lukkari, Catherine Leiendecker Foster, and the staff of the Advanced Research and Diagnostic Laboratory at the University of Minnesota for laboratory measurements; and Geert Molenberghs and Rod Little for comments and suggestions on the statistical analytic approaches.