Baseline characteristics of randomized participants in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE)

Deborah J. Wexler, Heidi Krause-Steinrauf, Jill P. Crandall, Hermes J. Florez, Sophia H. Hox, Alexander Kuhn, Ajay Sood, Chantal Underkofler, Vanita R. Aroda

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3 Scopus citations

Abstract

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 ofT2DM<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.

Original languageEnglish (US)
Pages (from-to)2098-2107
Number of pages10
JournalDiabetes care
Volume42
Issue number11
DOIs
StatePublished - Nov 1 2019

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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    Wexler, D. J., Krause-Steinrauf, H., Crandall, J. P., Florez, H. J., Hox, S. H., Kuhn, A., Sood, A., Underkofler, C., & Aroda, V. R. (2019). Baseline characteristics of randomized participants in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE). Diabetes care, 42(11), 2098-2107. https://doi.org/10.2337/dc19-0901