Baseline Characteristics of Participants in the Glycemia Reduction Approaches in Diabetes—A Comparative Effectiveness Study (GRADE)

GRADE is an NIDDK-sponsored, 36-center open-label randomized trial comparing the addition of one of the four most commonly used classes of glucose-lowering medications to metformin on long-term glycemic control and patient-centered outcomesin type 2 diabetes (T2D). Between June 2013 and June 2017, GRADE enrolled 5,047 patients age ≥ 30 years (y) (≥20 y in Native Americans [AI/AN]) at time of diagnosis, with T2D of 2 . Sixty-nine percent were treated for hypertension; 6.6% had a history of heart attack or stroke. Participant characteristics were comparable across treatment arms. GRADE recruited a diverse cohort to inform decision-making regarding the long-term clinical effectiveness of four major classes of glucose-lowering medications added to metformin. Uniquely, GRADE includes patients with an intermediate duration of diabetes who require a second glucose-lowering medication. Primary results from GRADE are expected in 2021. Disclosure D.J. Wexler: None. H. Krause-Steinrauf: None. A. Kuhn: None. J.P. Crandall: None. H. Florez: Advisory Panel; Self; Sanofi. C. Underkofler: None. S.H. Hox: None. M.C. Backman: None. V. Aroda: Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc., AstraZeneca, Calibra Medical, Eisai Inc., Sanofi. Consultant; Self; Sanofi. Research Support; Self; Theracos, Inc.. Employee; Spouse/Partner; Merck & Co., Inc.. Other Relationship; Self; American Diabetes Association. Consultant; Self; ADOCIA. G. Research Group: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases, National Heart, Lung, and Blood Institute. Other Relationship; Self; Bristol-MyersSquibb Company, Merck & Co., Inc., Novo Nordisk Inc., Sanofi-Aventis, Roche DiagnosticsCorporation, Becton, Dickinson and Company, Centers for Disease Control and Prevention, National Diabetes Education Program.