Researchers at Washington University School of Medicine in St. Louis are seeking volunteers for a study that compares the long-term benefits and risks of four widely used diabetes drugs. The drugs will be given in combination with metformin (Gulcophage®), the most commonly prescribed medication for treating type 2 diabetes.
Over a period of five years, the researchers will evaluate how the drugs affect blood-sugar levels, diabetes complications and quality of life, as well as the medications’ side effects.
“In addition to determining which medications control sugar most effectively over time, we will examine individual factors associated with better or worse response to different drugs,” said Janet B. McGill, MD, professor of medicine and principal investigator at the Washington University study site. “This is a long-term study that will provide targeted diabetes care at no cost to participants.”
Although short-term studies have shown that drugs to lower blood sugar can be effective when used with metformin, no long-term studies have been conducted to determine which combinations work best to keep diabetes under control.
The nationwide study is called the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study. It is expected to involve 5,000 patients across the country and 300 locally who have been diagnosed with type 2 diabetes within the past 10 years.
“Type 2 diabetes progresses slowly, over a long period of time,” said Barbara Linder, MD, PhD, the GRADE project officer at the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH). “This study will help us understand how different combinations of medications affect the disease over time and ultimately will help physicians make better choices for their patients’ long-term care.”
To be eligible for the study, people with diabetes may be taking metformin, but they cannot be on any other diabetes medication. During the study, all participants will take metformin along with a second medication randomly assigned from among four classes of medications that are approved for use with metformin by the U.S. Food and Drug Administration.
Three of the study drugs increase insulin levels. They are: sulfonylurea, DPP-4 inhibitor and GLP-1 agonist. The fourth option is a long-acting form of insulin.
Participants will receive free clinical evaluations and management of their diabetes medications throughout the course of the study, including at least four clinic visits a year.
GRADE (ClinicalTrials.gov number: NCT01794143) is supported under NIH grant U01 DK098246. Additional support, in the form of donation of supplies, comes from the National Diabetes Education Program, Sanofi-Aventis, Bristol-Myers Squibb, Novo Nordisk, Merck, BD Medical and Roche Diagnostics.
Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient-care institutions in the nation, currently ranked sixth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.