Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)
Authors: Deborah J. Wexler, Heidi Krause-Steinrauf, Jill P. Crandall, Hermes J. Florez, Sophia H. Hox, Alexander Kuhn, Ajay Sood, Chantal Underkofler, Vanita R. Aroda, Jill P. Crandall, Melissa Diane McKee, Janet Brown-Friday, Entila Xhori, Keisha Ballentine-Cargill, Sally Duran, Jennifer Lukin, Stephanie Beringher, Susana Gonzalez de la Torre, Lawrence Phillips, Elizabeth Burgess, Darin Olson, Mary Rhee, Peter Wilson, Tasha Stephanie Raines, Julie Costello, Chona Gullett, Maxine Maher-Albertelli, Folayan Morehead, Radhika Mungara, Saranjit Person, Louise Savoye, Mabil Sibymon, Sridhar Tanukonda, Carol Ann White, Leah Holloway, Cynthia Adams, April Ross, Ashok Balasubramanyam, Erica Gonzalez, Charlyne Wright, Priscilla Hollander, Erin Roe, Analyn Uy, Polly Burt, Lorie Estrada, Kris Chionh, Faramarz Ismail-Beigi, Corinna Falck-Ytter, Laure Sayyed Kassem, Ajay Sood, Margaret Tiktin, Bethany Cramer, Jacalyn Iacoboni, Maria V. Kononets, Tanya Kulow, Cynthia Newman, Katherine A. Stancil, Cristina Sanders, Lisa Tucker, Amanda Werner, Adrienne Krol, Gloria McPhee, Christine Patel, Linda Colosimo, Robin Goland, James Pring, Patricia Kringas, Jessica Tejada, Camille Hausheer, Harvey Schneier, Kelly Gumpel, Amanda Kirpitch, Jennifer B. Green, Hiba AbouAssi, Ranee Chatterjee, Mark N. Feinglos, Jennifer English, Shubi A. Jones, Jeanne B. Khan, Ronna P. Kimpel, Mary Zimmer, Barbara M. Furst, Connie R. Satterwhite, Kathryn Thacker, Kieren J. Evans Kreider, Amale Mather, Tonya Lteif, Nick Hamilton, Gabriela Patel, Marcia Riera, Vivian Jackson, Devin Pirics, Danielle Howard, Sloan Aguillar, Richard Hurt, Anders Bergenstal, Thomas Carlson, Mary Martens, Renae Johnson, Jamie Hill, Connie Hyatt, Marcia Jensen, Dianna Madden, Holly Martin, Wanda Willis, Rebecca Konerza, Kathleen Passi, Stephen Kleeberger, Michael Fortmann, Karen Herson, Harry Mularski, James Glauber, Britt Prihoda, Christina Ash, Phyllis Anne Carlson, Emily Ramey, Britta Schield, Kathy Torgrimson-Ojerio, Bryan Arnold, Elease Kauffman, Samantha Panos, Kristi Sahnow, Jennifer Bays, Jennifer Cook, Debra Gluth, Katrina Sasaki, Jennifer Schell, Camille Criscola, Suzi Friason, Sergey Jones, Joshua Nazarov, Negah Barzilay, Rachel Rassouli, Michelle Puttnam, Kia Curtis, Bonita Stokes, Cynthia Hollis, Roslin Sanders-Jones, Zakiah Nelson, Abby El-Haqq, Tu Kolli, Deborah Tran, James Wexler, Amy Meigs, Gianna Dushkin, Brittany Rocchio, Mike Chambers, Barbara Yepes, Hilary Steiner, Melody Dulin, Andrea Cayford, Lindsey DeManbey, Mallory Gurry, Kimberly Hillard, Christine Martin, Nopporn Stevens, Raquel Thangthaeng, Elyse Kochis, Valerie Raymond, Jean Ripley, Vanita Park, Adline Aroda, Amy Ghazi, Maria Loveland, Alexander Hurtado, Florence Kuhn, Hermes J. Mofor, Willy Marcos Florez, Jennifer Valencia, Lisset Marks, Ana K. Oropesa-Gonzalez, None Riccio, Ramfis Veliz, Miriam Nieto-Martinez, Andrew Gutt, Diana Ahmann, Farahnaz Aby-Daniel, Victoria Joarder, Carol Morimoto, Daisuke Sprague, Nancy Yamashita, Patricia Cady, Nadia Kirchhoff, Joseph Rivera-Eschright, Brianna Adducci, Alina Morales Gomez, Sophia H. Goncharova, Helen Hox, Michael Petrovitch, Victoria Matwichyna, Nina O. Jenkins, Renée R. Bermudez, Daniel S. Ishii, William T. Hsia, Frank L. Cefalu, Celeste Greenway, Erin Waguespack, Natalie King, Amy Haynes, Brandi Thomassie, Claire Bourgeois, Robert Hazlett, Sunder Henry, Schafer Mudaliar, Jeremy Boeder, Elsa Pettus, Catherine Diaz, Erick DeLue, Sylvia Castro, Jonathan Hernandez, Jeffrey M. Krakoff, Tina Curtis, Erica Killean, Enrique Joshevama, Denelle Diaz, Tracey Martin, Jeanine Karshner, F. Xavier Albu, Sylvaine Pi-Sunyer, Carol Frances, Emily Maggio, Joseph Ellis, Xiuqun Bastawrose, Mary Ann Gong, Phyllis Banerji, Daniel August, Necole M. Lorber, Debra H. Brown, Lorraine L. Josephson, Mari Thomas, Ajini Tsovian, Marlo H. Cherian, Motria M. Jacobson, M. Sue Mishko, Katherine Kirkman, John B. Bergamo, Jean Buse, Laura Dostou, April Young, Jeffrey Goley, Joseph F. Kerr, Sonia Largay, Juanita Guarda, Dawn Cuffee, Rachael Culmer, Hope Fraser, Samantha Almeida, Elizabeth Coffer, Lauren Debnam, Sarah Kiker, Kim Morton, Gail Josey, W. Timothy Fuller, Andrea Garvey, Dana Cherrington, Olivia Golson, Mary Catherine Griffith, April Robertson, Steve Agne, Robert M. McCullars, Jacqueline Cohen, Kimberly Craig, M. Colleen Kersey, Carla Rogge, Kathryn Wilson, Sonia Burton, Mary Beth Lipp, Neda Vonder Meulen, Emily Rasouli, Stephanie Schroeder, Chelsea Steiner, Chantal Baker, Sara Underkofler, William Douglass, Erin Sivitz, Laura Cline, Jennifer Knosp, Tamara McConnell, William H. Lowe, Rodica Herman, Meng H. Pop-Busui, Catherine Tan, Andrea Martin, Lynn Waltje, Rebecca Goodhall, Shihchen Eggleston, Stephanie Kuo, Nancy Bule, Elizabeth Kessler, Elizabeth R. LaSalle, Anne Seaquist, Anjali Bantle, Bruce Kumar, John Redmon, Tasma Bantle, Mary Harindhanavudhi, Michael Coe, Abdisa Mech, Lesia Taddese, Shannon Lesne, Cyrus Smith, Lisa Desouza, Vijay Kuechenmeister, Ana Laura Shivaswamy, Maria Grace Morales, Kris Rodriguez, Alissa Seipel, Jenna Alfred, Grace Eggert, William Lord, Renee Taylor, David S. Tillson, Allen Schade, Mark Adolphe, Elizabeth Burge, Janae Duran-Valdez, Doris Martinez, None Hernandez, Benjamin McGinnis, Elizabeth Pucchetti, Ralph A. Scripsick, Eugenio DeFronzo, Muhammad Cersosimo, Curtis Abdul-Ghani, Hector Triplitt, Rosa Irene Verastiqui, Kathryn Garza, Curtiss Wright, Philip Puckett, Chanhaeng Raskin, Soma Rhee, Lin Fan Abraham, Serey Jordan, Luisa Sao, Oralenda Morton, Laura Smith, Laura Osornio Walker, Rosa Schnurr-Breen, Robert Brian Ayala, Daytheon Kraymer, Kristina M. Sturgess, Steven E. Utzschneider, Lorena Kahn, Edward J. Alarcon-Casas Wright, Elaine C. Boyko, Dace L. Tsai, Basma N. Trence, Brenda K. Fattaleh, Karen M. Montgomery, Tessa Atkinson, Alexandra Concepcion, Cameron Kozedub, Samantha Moak, Tom A. Rhothisen, Stephanie Elasy, Laura Martin, Rita Shackelford, Nina Goidel, Janie Hinkle, Cynthia Lipps Hogan, Janet Lovell, Janet B. Myers, Maamoun McGill, Sarah Salam, Toni Kissel, Carol Schweiger, William Recklein, Patricia Tamborlane, Anne Gatcomb, Barbara Camp, Silvio Gulanski, Kim Inzucchi, Michele Pham, Katarzyna Alguard, Magalys Lessard, Elizabeth Perez, Abmaridel Magenheimer, David M. Montoza, John Nathan, Heidi Lachin, Mary Krause-Steinrauf, Henry B. Larkin, Barbara Burch, Andrew Linder, Naji Bremer, Michael Younes, Ionut Backman, C.J. Bebu, Anna Buys, Yuping Fagan Murphy, Michaela Gao, Stephanie Gramzinski, Elizabeth Hall, Alyssa Legowski, Joel Arey, Claire Bethepu, Pam Lund, None Mangat, Paula Dhaliwal, Emily McGee, Lisa Mesimer, Michael Ngo, Jesse Steffes, Amy Seegmiller, Valerie Saenger, Deanna Arends, Todd Gabrielson, Stuart Conner, Jolene Warren, Alexandra Day, Elsayed Z. Scrymgeour, Zhu-Ming Soliman, Charles Zhang, Julie Campbell, Lisa Hu, Susan Keasler, Yabing Hensley, Rada Li, Veronica Mihalcea, Lisa Perez-Rosas, Kenneth Prosser, Wen Resnicow, Hui Ye, Ping Shao, Jose Zhang, Danurys Luchsinger, Judith Sanchez, Erik Fradkin, Helen Groessl, Naomi Chong, Ivan Hillery, Paula Abdouch, Frances E. Brantley, Gay Broyles, Paul Canaris, Jeri J. Copeland, Warren L. Craine, Melissa S. Fein, Rebecca Lee, Vaughn Meiners, Hollis Meiners, James E. O’Neal, Edward Park, Jeanne Sledge, Alexander Steppel-Resnick, Barbara Turchin, Christiane S. Brooks-Worrell, Christopher B. Hampe, Jerry P. Newgard, Ali Palmer, John Shojaie, Lawrence Higgins, Sherita Fischer, Jeffery Golden, Aanand Gonzalez, Elizabeth Naik, Lynne Walker, Joanne M. Doner Lotenberg, Joanne Gallivan, Diane M. Lim, None Tuncer, Stephanie Behringer-Massera
Journal: Diabetes Care (2019)

OBJECTIVE GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort. RESEARCH DESIGN AND METHODS Participants were age ≥30 years at the time of diagnosis, with duration of T2DM &amp;lt;10 years, HbA1c 6.8–8.5% (51–69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine. RESULTS At baseline, GRADE’s 5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino. Duration of diabetes was 4.2 ± 2.8 years, with mean HbA1c of 7.5 ± 0.5% (58 ± 5.3 mmol/mol), BMI of 34.3 ± 6.8 kg/m2, and metformin dose of 1,944 ± 204 mg/day. Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke. Applying GRADE inclusion criteria to NHANES indicates enrollment of a representative cohort with T2DM on metformin monotherapy (NHANES cohort average age, 57.9 years; mean HbA1c, 7.4% [57 mmol/mol]; BMI, 33.2 kg/m2; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease). CONCLUSIONS The GRADE cohort represents patients with T2DM treated with metformin requiring a second diabetes medication. GRADE will inform decisions about the clinical effectiveness of the addition of four classes of diabetes medications to metformin.