GRADE, or Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, is the first clinical research effort designed to find out which of four Food and Drug Administration-approved diabetes medications, when combined with metformin (Glucophage®), is most effective for type 2 diabetes. The trial is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
Metformin remains the medication of choice to treat type 2 diabetes. However, even with a healthier lifestyle, most patients eventually need additional medication as their diabetes progresses and insulin cells retire. GRADE could help doctors identify which supplemental medication is best for that purpose.
“Diabetes is a major problem in the U.S., and patients are growing in number,” said Priscilla Hollander, MD, PhD, principal investigator of the GRADE Study for Baylor Research Institute. “We have a number of medications that we can use to treat diabetes, which is very good, but it’s still not clear how to use them in the best way.”
The GRADE study is enrolling 5,000 people with type 2 diabetes at 48 study sites, including the Baylor Endocrine Center in Dallas. Patients enrolled in the trial may be monitored for as long as five to seven years, Dr. Hollander said. The ultimate goal is to help them with glucose control.
“The GRADE study is a long-term study, which is necessary for a long-term disease like diabetes,” said David M. Nathan, MD, chairman of the GRADE study, director of the Massachusetts General Hospital Diabetes Unit, and professor of medicine at Harvard Medical School. “We hope to see which diabetes treatment is best for the population as a whole, as well as which one drug or combination of drugs may be best for specific individuals.”
People with diabetes participate in the GRADE study for a variety of reasons. Many want to give something back and help doctors learn how to better treat diabetes while identifying new options for their own diabetes management.
“I was not able to control my diabetes to a degree that was comfortable. I was lazy and my blood sugar was all over the map,” said Lance Metcalf, a GRADE study participant at the Dallas site. “The study has allowed me to focus a little bit more on how regulating my insulin levels can help me throughout the day.”
Three of the medications being tested are sulfonylurea, DPP-4 inhibitor and GLP-1 agonist, all of which increase insulin levels either directly or indirectly. The fourth therapy is a long-acting insulin medication. If these medication combinations prove to be the best treatments, the results could give patients the control they need to better manage their disease.
“I think it’s a study that’s trying to help us make better choices in treating diabetes,” Dr. Hollander said. “We want to know what is the simplest approach – and ultimately, the better approach – to help patients better care for their diabetes.”
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