‘Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study’ Reveals Key Characteristics Comparable with NHANES for Future Policy Decision in Diabetes Management

According to the Centers for Disease Control and Prevention, more than 30 million Americans have diabetes and 90 to 95 percent of them have type 2 diabetes. While the prevalence of type 2 diabetes is high, optimal management of the condition is not yet established. There are few studies with head-to-head comparisons of medications already approved in practice and advising on individualized therapy and population health strategies for prevention and control.

‘Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study’, also known as GRADE, is a multicenter, parallel-group clinical trial that is designed to compare the major drug classes that are currently used to treat type 2 diabetes. GRADE, which began in 2013, aims to provide better guidance to practitioners in the choice of medications when combined with metformin, the primary medication used to treat the condition.

In addition to lifestyle interventions, metformin is the most recommended form of medication to treat the condition. This medication is known for effectively managing glycemia, for its lack of associated hypoglycemia or weight gain, low cost, as well as for its evidence of long-term benefit and safety.

Most patients, however, require more than one form of medicine. According to a UK Prospective Diabetes Study, only 50 percent of patients with newly diagnosed diabetes could maintain stable glycemic levels with a single form of medication, declining to 25 percent in three years.

The goal of the GRADE study is to test commonly used medication combinations in randomly assigned treatment groups to aid in real-world clinical decision making. In combination with metformin, researchers are comparing glimepiride, sitagliptin, liraglutide, or insulin glargine.

Currently, there is a total of 5,047 participants that are currently enrolled in GRADE. Their baseline characteristics were recently reported in Diabetes Care, an American Diabetes Association journal. Researchers from 36 academic and medical centers in the United States, including the University of Miami Miller School of Medicine’s Department of Public Health Sciences and the Miami Veterans Affairs Healthcare System (VAHS) Geriatric Research, Education, and Clinical Center (GRECC), co-authored the report.

The report provided a description of the large randomized cohort who were 30 years of age or older, who have had type 2 diabetes for less than 10 years and who have relied primarily on metformin for treatment. The participants had a glycosylated hemoglobin of 6.8 to 8.5 percent at baseline.

There were approximately 20 percent African Americans and 18 percent Hispanics who are at high-risk for diabetes and its complications and who are similar in age, such as at around 57 years. They had a diabetes duration of approximately four years.

To assess the broader generalizability of GRADE, researchers also compared the cohort to a National Health and Nutrition Examination Survey (NHANES) cohort who met GRADE’s inclusion criteria. NHANES combines socio-demographic and clinical information, which expands our knowledge about the health of the U.S. population, and helps design programs and services.

“GRADE will inform the choice of the most durable diabetes medication added to metformin to achieve and maintain good glycemic control and prevention long-term complications while preserving the quality of life of patients with type 2 diabetes in the U.S. and beyond,” said Hermes Florez, M.D., Ph.D., M.P.H, professor of public health sciences at the Miller School of Medicine and director of the GRECC at the Miami Veterans Affairs Healthcare System, who co-authored the report.  

Written by Amanda Torres

Published on December 11, 2019