Accepted for Publication: July 25, 2013.
Published Online: February 3, 2014. doi:10.1001/jamainternmed.2013.13656.
Study concept and design: Williamson, Launer, Bryan, Coker, Lazar, Gerstein, Murray, Sullivan, Marcovina, Margolis, Miller.
Acquisition of data: Williamson, Bryan, Coker, Murray, Sullivan, Horowitz, Ding, Marcovina, Margolis, Barzilay, Ginsberg, Linz, Miller.
Analysis and interpretation of data: Williamson, Launer, Bryan, Lazar, Murray, Horowitz, L. Lovato, J. Lovato, Margolis, Davatzikos, Barzilay, Miller.
Drafting of the manuscript: Williamson, Launer, L. Lovato, J. Lovato, Miller.
Critical revision of the manuscript for important intellectual content: Williamson, Bryan, Coker, Lazar, Gerstein, Murray, Sullivan, Horowitz, Ding, Marcovina, Margolis, Davatzikos, Barzilay, Ginsberg, Linz, Miller.
Statistical analysis: L. Lovato, J. Lovato, Davatzikos, Miller.
Obtained funding: Williamson, Launer, Coker, Gerstein, Miller.
Administrative, technical, or material support: Williamson, Bryan, Coker, Lazar, Horowitz, Marcovina, L. Lovato, J. Lovato, Davatzikos, Barzilay, Ginsberg, Linz, Miller.
Study supervision: Williamson, Bryan, Coker, Sullivan, Davatzikos, Linz, Miller.
Conflict of Interest Disclosures: Dr Gerstein received consulting fees from sanofi-aventis, GlaxoSmithKline, Eli Lilly, Novo Nordisk, AstraZeneca, Bristol-Myers Squibb, Roche, Medtronic, Merck, Bayer, Bioavail, and Janssen-Ortho; received institutional grant support to McMaster University from sanofi-aventis, GlaxoSmithKline, Novo Nordisk, Merck, Pronova, Roche, Eli Lilly, and Boehringer Ingelheim; received lecture fees from sanofi-aventis, GlaxoSmithKline, Solvay, Boehringer Ingelheim, Servier, Bayer, Eli Lilly, Novo Nordisk, and Takeda; is a member of the board of Merck and Schering-Plough and of the global advisory board of Bristol-Myers Squibb/AstraZeneca; receives consulting fees from GlaxoSmithKline, Merck, Bristol-Myers Squibb, AstraZeneca, Regeneron/sanofi-aventis, Abbott, Roche, Isis/Genzyme, Novartis, and Pfizer; received institutional grant support to the Columbia University College of Physicians and Surgeons from Merck, Roche, Isis/Genzyme, and AstraZeneca; and received payment from Pfizer for development of an educational presentation. Dr Miller received consulting fees from Roche. No other disclosures were reported.
Funding/Support: This study was supported by the National Institute of Aging and the National Heart, Lung, and Blood Institute of the National Institutes of Health.
Role of the Sponsors: The funding sources contributed to the design and conduct of the study; the analysis and interpretation of the data; and preparation, review, and approval of the manuscript.
Group Information: The full trial protocol is given at https://www.accordtrial.org. Members of the ACCORD MIND Study Group include the following: Lenore J. Launer (principal investigator [PI]), and Robert Kramer, Intramural Research Program, National Institute on Aging, Bethesda, Maryland; Jeff D. Williamson (PI), Michael E. Miller, Laura H. Coker, James Lovato, Laura Lovato, John Hepler, Deborah Felton, Leanne Andrews, S. Mayer, C. Carter, and Nancy Woolard (Wake Forest School of Medicine, Winston-Salem, North Carolina [coordinating center]); R. Nick Bryan (PI), Lisa Desiderio, Christos Davatzikos, Michael Bilello, Elias R. Melhem, D. Koka, Evi Parmpi, Harsha Battapady, and Guray Erus (Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia [MRI Reading Center]); Hertzel C. Gerstein (MIND PI), Salim Yusuf, Sarah Capes, Zubin Punthakee, Tali Cukierman-Yaffe, (MIND investigator), Michael Vallis, Stephanie Hall, P. Mackie, V. Reiding, Rosalie Russo, Beth Tadeson, and Kim Thompson (Canadian Diabetes Outcome Researchers, Population Health Research Institute, Hamilton Health Sciences/McMaster University, Hamilton, Ontario [Canadian CCN]); Sarah Capes, Zubin Punthakee, Ada Smith, and Teresa Valla (McMaster Medical Centre [Canadian clinical site]); Carol Joyce, Minnie Parsons, and Bernadette Rowe (Memorial University of Newfoundland, St John’s [Canadian clinical site]); Irene Hramiak, Melissa Gehring, and Sue Tereschyn (St Joseph’s Health Care London, London, Ontario [Canadian clinical site]); Heather Lochnan, Julie Maranger, Martha McLean, and Ron Sigal (Division of Endocrinology and Metabolism, Ottawa Hospital, Ottawa, Ontario [Canadian clinical site]); Vincent Woo, Lori Berard, Teresa Anderlic, Adrian Bernard, and Al-Noor Mawani (Winnipeg Regional Health Authority, Health Science Center, Diabetes Research Group, Winnipeg, Manitoba [Canadian clinical site]); Carl Abbott, Ehud Ur, Glenda McCarthy, Melanie Yuille, Heather Murdock, Tabitha Palmer, and Anne Marie Patterson (Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia [Canadian clinical site]); Richard H. Grimm, Jr, Brenda Kirpach, Marian M. Bartkoske, Colleen M. Boyce, Nicole Druckman, Arlene M. Gillett, Julie A. Levin, Gloria J. Livingston (MIND investigator), Anne M. Murray (MIND PI), Karen L. Margolis (MIND investigator), and Charles Truwit (MIND MRI investigator) (Berman Center for Outcomes & Clinical Research, Minneapolis, Minnesota [Minnesota-Iowa CCN]); Sara Kempainen, Marcia Madden, Kathleen Hall, and Kim Wood (Hennepin ACCORD Clinic, Minneapolis [Minnesota-Iowa clinical site]); Richard Bergenstal, R. Cuddihy, Bradley Davick, Susan List, Diane Whipple, Charlotte Ashanti, and D. Kendall (International Diabetes Center, Minneapolis [Minnesota-Iowa clinical site]); Elizabeth R. Seaquist, Michael V. Mech, Luke E. Benedict, Debra J. Demmon, Anjali F. Kumar, Shaina M. Martinson, Sherry A. Miller, C. Pease, Jyothi P. Rao, J. Bruce Redmon, Joyce E. Swanson, Julie K. Wimmer, Yolanda Okorocha, M. Stiles, C. Kodl, and C. Chadha (University of Minnesota, Minneapolis [Minnesota-Iowa clinical site]); Kevin A. Peterson, Lea A. Seaquist, Christy Boese, Tai J. Mendenhall, Andrea M. Peterson, Amanda Rudelt, and Terri M. Schrock (Phalen Village Clinic, University of Minnesota, St Paul [Minnesota-Iowa clinical site]); JoAnn Sperl-Hillen, Patrick J. O’Connor, Maureeen E. Busch, A. Chung, Becky K. Klein, Nicole Krugen, Theresa Bunkers-Lawson, Heidi L. Ekstrom, Heidi S. Gunderson, Bonnie M. Johnson, John H. MacIndoe, Donna J. Prewedo, Janet L. Rawl, Colleen M. Roethke, Mary Quinlan, Carol R. Fox, Beverly M. Bate, Q. T. Cao, Melissa M. Ohnstad, and P. J. Meyers (Department of Endocrinology, Riverside Health Partners Clinic, Minneapolis [Minnesota-Iowa clinical site]); William I. Sivitz, Sheila M. Wayson, Theresa A. Lower, Kurt A. Ochs, and Denise Wells (Health Care Diabetes Clinical Research and Programs, University of Iowa, Iowa City [Minnesota-Iowa clinical site]); Ronald M. Lazar (MIND PI), Kevin Slane (MIND investigator), and Carlos R. Lopez-Jimenez (MIND investigator) (Columbia University College of Physicians and Surgeons, New York, New York [Northeastern CCN]); Joy Hirsch, Truman R. Brown, Stephen M. Dashnaw, Jamie Cruz-Lobo (Columbia University Medical Center, New York [MIND MRI Center]); Ulrich K. Schubart, Jeanne Russo, Nilda Vincenty, and Katherine Ibarrando (Jacobi Medical Center, Bronx, New York [Northeastern clinical site]); Michael H. Alderman, Lillian Carroll, Mary Jo Sanguily, Anna C. Mayer, and Lee Ramos (Albert Einstein General Clinical Research Center, Bronx, New York [Northeastern clinical site]); David Brillon, Juan Cordero, Raymond Chiong, Karen Hyams, and Cassia Charles (Cornell Internal Medicine Associates, New York, New York [Northeastern clinical site]); Arnaud Bastien, Susan Grudzinski, Patrick Niblack, L. Abreu, Karen Brown, Monica Casale, Denise Dougherty, Dawn Linneman, Miriam A. Salvador, Pamela Zee, Daniel Hyman, Diane Atabek, Jenifer Miranda, Indira Kumar, and Charlotte Baker (The Cooper Health System, Cherry Hill, New Jersey [Northeastern clinical site]); Daniel F. Brautigam, Rosemary Fischer, Deanna M. Scharf, E. Brautigam, Barbara Nunn, June M. Chiarot, and Chris Flanders (Great Lakes Medical Clinic Research, Westfield, New York [Northeastern clinical site]); Robin Goland, Patricia Kringas, Jennifer Montes, and Janiel Belle (Naomi Berrie Diabetes Center, New York, New York [Northeastern clinical site]); Asqual Getaneh, Jennifer Ramirez, G. Kranwinkel, and Erida Vasquez (Ambulatory Care Network at Columbia University [Northeastern clinical site]); Daniel S. Donovan, Gerardo Febres, Clara Hernandez, Mary Anne Jonaitis, and Carlos Lopez-Jimenez (Irving Diabetes Research Unit, New York, New York [Northeastern clinical site]); Mary Ann Banerji, Margaret Norton, Priti Patel, and Sondra Hirsch (State University of New York Downstate Medical Center, Brooklyn, and New York Kings County, Brooklyn [Northeastern clinical sites]); Saul Genuth, Faramarz Ismail-Beigi, Mark Thibonnier, Laura Vargo, Carol Kelly, Theresa Bongorno, Amanda Dolish (MIND investigator), Laura Pavlik (MIND investigator), Margaret Tiktin (MIND investigator), Souzan Isteitieh, Andrew Bartlett, Kimberly Yee, Tanya Kulow, and Karen A. Horowitz (MIND PI); (Division of Clinical and Molecular Endocrinology, Case Western Reserve University, Cleveland, Ohio [Ohio-Michigan CCN]); Jeffery Sunshine and Mark Clampitt (University Hospitals of Cleveland, Department of Radiology, Cleveland [MIND MRI Center]); Faramarz Ismail-Beigi, A. Krikorian, L. Moore, Lynn Richardson, E. Coles-Herman, Jamie Frankino, Ajay Sood, Leighanne Hustak, Mary Julius, Laura Pavlik, Toni Ross, Lucy Long, Mary K. Sullivan, MD, Louise Strauss, Kim Behm, Farideh Eskandari, Cynthia Hall, Debbie Hayes, Karen A. Horowitz, Souzan Isteitieh, Zuhayr Madhun, Eileen Seeholzer, Julie Shina, Harris Taylor, and Adrian Schnall (Division of Endocrinology, University Hospitals of Cleveland, and University Hospitals Westlake Medical, Cleveland [Ohio-Michigan clinical site]); Laurie S. Sadler, Mary Griffith, Ann Hornsby, Karen Klyn, Ellen Ospelt, Lucy Long, Mariellen DeSmit, Peggy McCann, Nicole Pero Schmidt, Tanya Kulow, and Tania Zaletal (Lipid Research Center, St Vincent Charity Hospital, Cleveland [Ohio-Michigan clinical site]); Adrian. M. Schnall, Lori Dragmen, Renee Ellert, Jonathon Smith, J. Leksan, and T. Sussman (University Suburban Health Center, South Euclid, Ohio [Ohio-Michigan clinical site]); Faramarz Ismail-Beigi, Leighanne Hustak, Mary Julius, William Schwing, Cynthia Hall, Karen A. Horowitz, Souzan Isteitieh, Cynthia Johnson, Elizabeth Kern, Mary Ann Richmond, Lynn Richardson, Kimberly Roberts, Julie Shina, Pam Suhan, Harris Taylor, Sharon Watts, J. Martin, and G. J. Strauss (Department of Medicine, Cleveland Veterans Affairs Medical Center, and Ravenna Community Based Outpatient Clinic, Cleveland [Ohio-Michigan clinical site]); Basil Akpunonu, Roberto Franco-Saenz, Jenny Gilmore, Maureen Gilmore, Patricia Ross, Becky Bauer, Rodica Pop-Busui, Jason Roman, and Zachary Blust (Department of Medicine, Medical University of Ohio, Ruppert Health Center, Toledo [Ohio-Michigan clinical site]); A. Thomas, Dorothy M. Kahkonen, Terra Cushman, Melissa Roman, Ann M. Stys, Karen White, Mary Austin, Cindy Chatterton, J. Kimberly Francis, Charlene Jones, David Kruger, Amanda McLellan, Fred Whitehouse, E. Higgins, Shiri Levy, and A. Schoenherr (Henry Ford Health System–New Center One, Detroit, Michigan [Ohio-Michigan clinical site]); David C. Goff, Jr, John H. Summerson, Lenore Crago, Caroline S. Blackwell, Alain Bertoni, Rhonda L. Blaine, Julienne K. Kirk, Rhonda L. Spach, Jeff Williamson, Jorge Calles, Jeff Katula, Dorothy B. Wishnietsky, Leslie Gordineer, and Jingzhong Ding (MIND investigator); (Divison of Public Health Sciences, Wake Forest School of Medicine [Southeastern CCN]); Sandy Kaminsky and Debra Fuller (Center for Biomolecular Imaging, Wake Forest School of Medicine [MIND MRI Center]); Mark N. Feinglos, Jennifer Jones, and Georgianne Gedon-Lipscomb (Duke University Medical Center, Durham, North Carolina [Southeastern clinical site]); Hal H. Atkinson, Judy Stanfield, and Thania Delvalle-Fagan (Department of Geriatrics/Gerontology, Wake Forest School of Medicine [Southeastern clinical site]); Carolyn F. Pedley and Sally Mauney (Downtown Health Plaza, Winston-Salem, North Carolina [Southeastern clinical site]); John B. Buse, Michelle D. Duclos, Ruth E. Kirby, A. Goley, and K. Vukojicik (Diabetes Care Center, University of North Carolina, Chapel Hill [Southeastern clinical site]); Jerry L. Miller, W. Besterman, Susan M. Norton, and M. Surgener (Holston Medical Group, Kingsport, Tennessee [Southeastern clinical site]); Michael Dulin, Tom Barringer, Carol Morris, and S. Norton (Carolinas Medical Center Family Practice, Charlotte, North Carolina [Southeastern clinical site]); Robin Peace, Dennis O. Stuart, Janice Strickland, Lynn Cummings, and Judy Stanfield (Robeson Health Care Corporation, Fairmont Clinic, Fairmont, North Carolina [Southeastern clinical site]); Robin Peace, Janice Strickland, Lynn Cummings, and Judy Stanfield (Robeson Health Care Corporation, Julian T. Pierce Clinic, Pembroke, North Carolina [Southeastern clinical site]); John R. Crouse III and Julie Ellis (Departments of Internal Medicine and Endocrinology, Wake Forest School of Medicine [Southeastern clinical site]); Vivian Fonseca, J. John-Kalarickal, Sharice M. Leger, and Kartik Munshi (Tulane University Health Science Center, New Orleans, Louisiana [Southeastern clinical site]); Joshua Barzilay, Katrina Bader, and Melanie Eley (Kaiser Permanente, Crescent Center Medical office [Southeastern clinical site]); Jeffery L. Probstfield, Mark D. Sullivan (MIND PI), Connie Kingry, Janice M. Johnson (MIND investigator), A. S. Line, Marshall A. Corson, R. Knopp, Edward Lipkin, MD, C. Griswold, K. Liebert, Ashley Brown, Dawn Juliano, Ella Mae Kurashige, Stephanie Moberg, and J. Leader (University of Washington, Seattle [Western CCN]); Kevin Ariani and Haydee Gutierrez (Cardiovascular Center, Northridge Hospital Medical Center, Northridge, California [Western MIND site]); Richard Failor, Allan Ellsworth, Nikki Jackson, and Kim Capoccia (University of Washington Medical Center at Roosevelt, Family Medical Center, Seattle [Western MIND site]); Rex Force, Mimi Macdonald, Shannon Koester, and Krysti Pettingill (Department of Family Medicine, Idaho State University, Pocatello [Western MIND site]); Peter E. Linz, Patricia V. Pepper, Susan Griffin, Janet Kozlowski, Marty Engle, and Paige Gutierrez (Cardiology Division, Naval Medical Center San Diego, San Diego, California [Western MIND site]); Matthew C. Riddle, Patricia A. McDaniel, Sarah C. Gammell-Matthews, Brittany MacNeil, Sharlene K. DesRochers, and Reyna Swift (Section of Diabetes, Oregon Health and Science University, Portland [Western MIND site]); Carol Wysham, Debbie Weeks, and Linda Kuntsmann (Washington State University, Spokane [Western MIND site]); Jim Dudl, Patricia Wu, Laura Lyons, Barbara House, Margaret Murray, Anton Palma, and Rachel Stevenson (Kaiser Endocrine Clinic, San Diego, California [Western MIND site]); and George Dailey, Athena Philas-Tsimikas, Anna Giannella, A. Bravo-Medina, Melissa Jacobson, Estela Farro, S. Cruz, Noemi Juarez, and Connie Dadkhah (Clinical Trials Department, Whittier Institute for Diabetes, La Jolla, California [Western MIND site]).
Correction: This article was corrected on February 5, 2014, for an error in the Abstract and on February 7, 2014, for an error in the byline.