Home Type 2 GRADE Study Researchers Present Expanded Results of NIH-Sponsored Major Comparative Study of Hypoglycemic Drugs in Type 2 Diabetes | Milken Institute School of Public Health

GRADE Study Researchers Present Expanded Results of NIH-Sponsored Major Comparative Study of Hypoglycemic Drugs in Type 2 Diabetes | Milken Institute School of Public Health

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WASHINGTON (March 25, 2024)—Diabetes affects more than 1 in 10 Americans, or more than 38 million people. People with diabetes who maintain their blood sugar levels in a near normal range generally have a much lower risk of developing diabetic complications, such as heart, kidney, and eye disease. The challenge is that most people with diabetes require multiple medications to control blood sugar levels over the long term.

The Glycemic Lowering Approaches in Diabetes: Comparative Effectiveness (GRADE) study was conducted from 2013 to 2021 at 36 centers and nine subsites in the United States. The George Washington University (GW) Center for Biostatistics served as the coordinating center. Dr. John Lachin served as GRADE principal investigator and senior biostatistician. Along with Dr. Lachin, Coordinator His Center is led by Heidi Klaus Steinlauf, MSc, as Project Director and Senior Investigator of the GRADE Study and Principal Investigator of the Emotional Distress Sub-Study, and Dr. Naj Younes, as Senior Co-Investigator of GRADE. I did. Principal investigator of the genetics substudy. The entire GW Biostatistics Center research team was instrumental in successfully completing this study.

“We would like to thank everyone who volunteered to participate in the GRADE study and everyone at the George Washington University Biostatistics Center and other research facilities across the country who worked diligently on this important research.”

NIDDK awards Dr. Lachin, principal investigator at George Washington University, third consecutive U01 grant totaling $250 million for funding agreements with coordinating centers and central units of clinical centers and research Did. Learn more about the study, participating centers, and study results. www.gradestudy.org

The study was designed to compare the four main drugs approved by the FDA to treat diabetes in combination with the usual first-line drug, metformin. Key findings focused on relative differences in blood sugar levels (blood sugar levels) and the occurrence of cardiovascular diseases such as heart attacks and strokes. of New England Medical Journal September 2022.

10 scientific papers published in April issue diabetes care We report other important differences between four drugs commonly used to treat type 2 diabetes.

The GRADE study included more than 5,000 volunteer participants with type 2 diabetes from various racial and ethnic groups. These were studied over his five years, during which insulin glargine, liraglutide, glimepiride, and sitagliptin were compared. The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.

Beyond the differences in glycemic control between four diabetes medications shown in previous publications, the results of the current study investigated individual characteristics associated with decreases and increases in average blood glucose levels over time. . For example, the main reasons for not maintaining good glycemic control are younger age and higher baseline blood sugar levels. Understanding these factors can help identify people who would benefit from more aggressive diabetes management. Another series of analyzes found that adding liraglutide to metformin improved quality of life 1 year after starting treatment, but that this benefit disappeared after that time. Improvements with liraglutide were related to the degree of weight loss, especially among those who were the highest at baseline.

Of note, assignment to insulin therapy was well accepted by participants, with even better compliance than other medications, and there was no negative impact of insulin therapy on participants’ diabetes-related distress. In fact, treatment with insulin and another injectable drug, liraglutide, reduced the suffering associated with diabetes. These findings largely debunk the myth that patients cannot tolerate insulin therapy or that their quality of life deteriorates once they begin insulin therapy.

Sensitivity to insulin action and insulin secretion from pancreatic beta cells are known to be important factors in type 2 diabetes. The roles of each are reported in separate papers. Loss of insulin secretion was critically associated with progressive deterioration of glycemic control with all four drugs, and decreased insulin sensitivity contributed to treatment outcome.

The two most common causes of death during the study period were cardiovascular disease and cancer, which did not differ between the four treatment groups.

“GRADE has previously shown which drugs are most effective in achieving and maintaining blood sugar goals over time. Our findings will help patients and their healthcare providers choose the best drug to treat diabetes. “This study provides additional information about the relative benefits and risks of drugs that can be helpful for patients,” said Dr. David M. Nathan, GRADE study chair and president of Massachusetts General Hospital. Diabetes Center.

The GRADE study was supported by a grant from NIDDK (U01DK098246). Additional support was provided by the NIH’s National Heart, Lung, and Blood Institute, National Institute of General Medical Sciences, and National Center for the Advancement of Translational Sciences. Centers for Disease Control and Prevention. and the American Diabetes Association. The Department of Veterans Affairs provided resources and facilities. Material support in the form of donated medicine and supplies is being provided by Becton Dickinson & Company, Bristol-Myers Squibb, Merck & Co., Novo Nordisk, Roche Diagnostics, and Sanofi. ClinicalTrials.gov number: NCT01794143.


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