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

  • Wexler, Deborah J1
  • Krause-Steinrauf, Heidi2
  • Crandall, Jill P3
  • Florez, Hermes J4
  • Hox, Sophia H5
  • Kuhn, Alexander6
  • Sood, Ajay7
  • Underkofler, Chantal8
  • Aroda, Vanita R6
  • 1 Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA [email protected]
  • 2 The George Washington University Biostatistics Center, Rockville, MD.
  • 3 Albert Einstein College of Medicine, Bronx, NY.
  • 4 University of Miami, Geriatric Research, Education, and Clinical Center-Miami Veterans Affairs Healthcare System, Miami, FL.
  • 5 Pacific Health Research & Education Institute, Honolulu, HI.
  • 6 MedStar Health Research Institute, Hyattsville, MD.
  • 7 Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH.
  • 8 University of Colorado, Denver, Denver, CO.
Published Article
Diabetes care
Publication Date
Nov 01, 2019
DOI: 10.2337/dc19-0901
PMID: 31391203


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. Participants were age ≥30 years at the time of diagnosis, with duration of T2DM <10 years, HbA1c 6.8-8.5% (51-69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine. 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). 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. © 2019 by the American Diabetes Association.

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