• Media type: E-Article
  • Title: Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)
  • Contributor: Wexler, Deborah J.; Krause-Steinrauf, Heidi; Crandall, Jill P.; Florez, Hermes J.; Hox, Sophia H.; Kuhn, Alexander; Sood, Ajay; Underkofler, Chantal; Aroda, Vanita R.; Crandall, Jill P.; McKee, Melissa Diane; Brown-Friday, Janet; Xhori, Entila; Ballentine-Cargill, Keisha; Duran, Sally; Lukin, Jennifer; Beringher, Stephanie; Gonzalez de la Torre, Susana; Phillips, Lawrence; Burgess, Elizabeth; Olson, Darin; Rhee, Mary; Wilson, Peter; Raines, Tasha Stephanie; [...]
  • Published: American Diabetes Association, 2019
  • Published in: Diabetes Care
  • Extent: 2098-2107
  • Language: English
  • DOI: 10.2337/dc19-0901
  • ISSN: 0149-5992; 1935-5548
  • Keywords: Advanced and Specialized Nursing ; Endocrinology, Diabetes and Metabolism ; Internal Medicine
  • Abstract: <jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESEARCH DESIGN AND METHODS</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>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.</jats:p> </jats:sec>
  • Description: <jats:sec>
    <jats:title>OBJECTIVE</jats:title>
    <jats:p>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.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>RESEARCH DESIGN AND METHODS</jats:title>
    <jats:p>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.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>RESULTS</jats:title>
    <jats:p>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).</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>CONCLUSIONS</jats:title>
    <jats:p>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.</jats:p>
    </jats:sec>
  • Footnote:
  • Access State: Open Access