Diabetes affects more than 1 in 10 people. or more than 38 million -; Americans. 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 designed to compare the four main drugs approved by the FDA to treat diabetes in combination with metformin, the usual first-line drug. I did.
The 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. New England Medical Journal In September 2022. Ten scientific papers were subsequently published in the April issue. diabetes care reported further important differences between four drugs commonly used to treat type 2 diabetes.
The GRADE study was conducted from 2013 to 2021 at 36 centers and nine sub-sites in the United States, including the Pennington Biomedical Research Center in Baton Rouge, and enrolled 5,000 volunteer participants with type 2 diabetes of diverse races and ethnicities. More than one participated. They participated over a 5-year period 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 those 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 among the four treatment groups.
GRADE has previously shown which drugs are most effective at achieving and maintaining blood sugar goals over time. The results of the current study provide additional information about the relative benefits and risks of drugs and should help patients and their healthcare providers choose the most appropriate drug for the treatment of diabetes. ”
Dr. David M. Nathan, GRADE Research Chair and Director, Massachusetts General Hospital Diabetes Center
Doctors. William Cefal and Daniel Shea served as GRADE principal investigators, and Dr. Frank Greenway and Celeste Wagspack served as co-investigators. Pennington Biomedical’s entire clinical trials department was also instrumental in the successful completion of this study.
“Diabetes and obesity are two major diseases that we study every day at Pennington Biomedical. Learning more about the drugs currently used to treat these diseases will help us eliminate them completely. “This is an important step toward achieving this goal,” said John Kirwan, executive director of Pennington Biomedical. “We would like to thank everyone who volunteered for the GRADE study and everyone at Pennington Biomedical and other research facilities across the country who were involved in this important research.”
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.