{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T15:40:31Z","timestamp":1777650031125,"version":"3.51.4"},"reference-count":36,"publisher":"American Diabetes Association","issue":"11","license":[{"start":{"date-parts":[[2019,10,21]],"date-time":"2019-10-21T00:00:00Z","timestamp":1571616000000},"content-version":"vor","delay-in-days":75,"URL":"http:\/\/www.diabetesjournals.org\/content\/license"}],"funder":[{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U34-DK-088043"],"award-info":[{"award-number":["U34-DK-088043"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01-DK-098246"],"award-info":[{"award-number":["U01-DK-098246"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2019,11,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <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>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>Participants were age \u226530 years at the time of diagnosis, with duration of T2DM &amp;lt;10 years, HbA1c 6.8\u20138.5% (51\u201369 mmol\/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>At baseline, GRADE\u2019s 5,047 randomized participants were 57.2 \u00b1 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 \u00b1 2.8 years, with mean HbA1c of 7.5 \u00b1 0.5% (58 \u00b1 5.3 mmol\/mol), BMI of 34.3 \u00b1 6.8 kg\/m2, and metformin dose of 1,944 \u00b1 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 \u00b1 2.5 years; and 7.2% with a history of cardiovascular disease).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <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>\n               <\/jats:sec>","DOI":"10.2337\/dc19-0901","type":"journal-article","created":{"date-parts":[[2019,8,8]],"date-time":"2019-08-08T04:19:19Z","timestamp":1565237959000},"page":"2098-2107","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":42,"title":["Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)"],"prefix":"10.2337","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct01794143","registry":"10.18810\/clinical-trials-gov","type":"results"},{"clinical-trial-number":"nct01794143","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6979-402X","authenticated-orcid":false,"given":"Deborah 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