Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)
Open Access
- 7 August 2019
- journal article
- research article
- Published byĀ American Diabetes AssociationĀ inĀ Diabetes Care
- Vol.Ā 42Ā (11), 2098-2107
- https://doi.org/10.2337/dc19-0901
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 ā„30 years at the time of diagnosis, with duration of T2DM 1c 6.8ā8.5% (51ā69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine. RESULTS At baseline, GRADEās 5,047 randomized participants were 57.2 Ā± 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 Ā± 2.8 years, with mean HbA1c of 7.5 Ā± 0.5% (58 Ā± 5.3 mmol/mol), BMI of 34.3 Ā± 6.8 kg/m2, and metformin dose of 1,944 Ā± 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 Ā± 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.Keywords
Funding Information
- National Institute of Diabetes and Digestive and Kidney Diseases (U34-DK-088043, U01-DK-098246)
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