American Diabetes Association
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Mortality in the Glycemia Reduction Approaches in Type 2 Diabetes (GRADE) Study: A Comparative Effectiveness Randomized Clinical Trial

posted on 2024-01-22, 20:22 authored by Mary Ann Banerji, John B. Buse, Naji Younes, Heidi Krause-Steinrauf, Adline Ghazi, Melissa Lee, Jean Park, Rodica Pop-Busui, Chantal Underkofler, Stephen P. Fortmann

Objective: We report mortality outcomes in the GRADE trial among people with type 2 diabetes diagnosed within 10 years and no recent history of cardiovascular events or cancer.

Research Design and Methods: Overall mortality rates and major causes of death were assessed over average 5-year follow-up. Cause of death was adjudicated centrally by a committee masked to treatment assignment. We examined baseline covariates and the 10-year Framingham Risk Score for associations.

Results: Mortality rate was low (0.59 per 100 participant-years). Participants who died during follow-up were likely to be older, male, have a history of hypertension, smoking, and moderate albuminuria. The two most common underlying causes of death were cardiovascular (38.5%) and cancer (26.8%). There were no differences by treatment group.

Conclusions: Among people with diabetes of relatively short duration, cause of death was varied. Attention to health risks beyond cardiovascular diseases is warranted.


The GRADE Study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under Award Number U01DK098246. The planning of GRADE was supported by a U34 planning grant from the NIDDK (U34-DK-088043). 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 also provided funding support. The Department of Veterans Affairs provided resources and facilities. Additional support was provided by grant numbers P30 DK017047, P30 DK020541-44, P30 DK020572, P30 DK072476, P30 DK079626, P30 DK092926, U54 GM104940, UL1 TR000439, UL1 TR000445, UL1 TR001108, UL1 TR001409, 2UL1TR001425, UL1 TR001449, UL1 TR002243, UL1 TR002345, UL1 TR002378, UL1 TR002489, UL1 TR002529, UL1 TR002535, UL1 TR002537, 2UL1 TR001425 and UL1 TR002548. Educational materials were provided by the National Diabetes Education Program. Material support in the form of donated medications and supplies has been provided by Becton, Dickinson and Company, Bristol-Myers Squibb, Merck & Co., Inc., Novo Nordisk, Roche Diagnostics, and Sanofi. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The GRADE Study Research Group is deeply grateful to our participants whose loyal dedication made GRADE possible.


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