TY - JOUR
T1 - Baseline characteristics of randomized participants in the glycemia reduction approaches in diabetes
T2 - A comparative effectiveness study (GRADE)
AU - Wexler, Deborah J.
AU - Krause-Steinrauf, Heidi
AU - Crandall, Jill P.
AU - Florez, Hermes J.
AU - Hox, Sophia H.
AU - Kuhn, Alexander
AU - Sood, Ajay
AU - Underkofler, Chantal
AU - Aroda, Vanita R.
N1 - Funding Information:
Acknowledgment. The authors thank Catherine Cowie, National Institute of Diabetes and Digestive and Kidney Diseases, and Danita Byrd-Clark, Social & Scientific Systems, for their guidance and support for the NHANES analysis. Funding. The GRADE Study is supported by the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases (U34-DK-088043 and U01-DK-098246). The American Diabetes Association supported the initial planning meeting for the U34 proposal. The National Heart, Lung, and Blood Institute and the Centers for Disease Control and Prevention are also providing funding support. Educational materials have been provided by the National Diabetes Education Program. Material support in the form of donated medications and supplies has been provided by BD, Bristol-Myers Squibb, Merck, Novo Nordisk, Roche Diagnostics, and Sanofi. Duality of Interest. V.R.A. reports grants and personal fees from AstraZeneca/Bristol-Myers Squibb, Novo Nordisk, and Sanofi, personal fees from BD and Zafgen, grants from Calibra, Eisai, Janssen, and Theracos, other from Adocia, and other from Merck, outside the submitted work. No other potential conflicts of interest relevant to this article were reported. Author Contributions. D.J.W. contributed to the design, interpretation of data, supervision and management of the research, writing, and critical review of this manuscript. H.K.-S. contributed to the design, acquisition of data, statistical analysis, interpretation of data, supervision and management of research, writing, and critical review of this manuscript. J.P.C. contributed to the design, acquisition and interpretation of data, and critical review of this manuscript. H.J.F. contributed to the design, interpretation of data, and critical review of this manuscript. S.H.H. contributed to the acquisition of data and critical review of this manuscript. A.K. contributed to the acquisition of data, writing, and critical review of this manuscript. A.S. contributed to the acquisition and interpretation of data, supervision and management of research, and critical review of this manuscript. C.U. contributed to the acquisition of data and critical review of the manuscript. V.R.A. contributed to the design, acquisition, and interpretation of data, supervision and management of research, writing, and critical review of this manuscript. All authors affirm that authorship is merited based on the International Committee of Medical Journal Editors authorship criteria. D.J.W. and H.K.-S. are the guarantors of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. Parts of this study were presented in abstract form at the 78th Scientific Sessions of the American Diabetes Association, Orlando, FL, 22–28 June 2018.
Funding Information:
The GRADE Study is supported by the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases (U34- DK-088043 and U01-DK-098246). The American Diabetes Association supported the initial planning meeting for the U34 proposal. The National Heart, Lung, and Blood Institute and the Centers for Disease Control and Prevention are also providing funding support. Educational materials have been provided by the National Diabetes Education Program. Material support in the form of donated medications and supplies has been provided by BD, Bristol-Myers Squibb, Merck, Novo Nordisk, Roche Diagnostics, and Sanofi.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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.
AB - 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.
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U2 - 10.2337/dc19-0901
DO - 10.2337/dc19-0901
M3 - Article
C2 - 31391203
AN - SCOPUS:85072627275
VL - 42
SP - 2098
EP - 2107
JO - Diabetes Care
JF - Diabetes Care
SN - 1935-5548
IS - 11
ER -