Could metformin, one of the most widely used drugs for type 2 diabetes, help to protect heart health and reduce complications in people with type 1 diabetes (T1D)? JDRF is funding a new trial to answer these questions.
The REMOVAL study (REducing with MetfOrmin Vascular Adverse Lesions in T1D)—one of the largest trials targeted at reducing complications ever funded by JDRF—has begun enrolling adults to test whether metformin, when used in combination with insulin therapy, can prevent or reduce the risk of cardiovascular complications in people with T1D. “Given what we know about metformin, we are eager to learn whether its benefits could have a positive impact on the health and lives of people with type 1 diabetes who are at risk for cardiovascular problems,” says Dr. John Petrie, professor of diabetic medicine at the University of Glasgow and the lead investigator of the study.
Metformin is an oral drug recommended for first-line (initial) treatment for people with type 2 diabetes to help control blood glucose levels. It has a proven safety record. Metformin is sometimes used in the treatment of T1D to lower insulin requirements by reducing insulin resistance and it may also help to reduce cholesterol levels.
REMOVAL will test whether adding three years of metformin therapy to insulin therapy in adults with T1D reduces thickening in the walls of blood vessels. This thickening, called “intima-media thickness,” is known to predict future heart attacks and strokes, and can be measured painlessly in the neck with ultrasound technology. REMOVAL will also test metformin’s effects on the control of T1D and treatment satisfaction, as well as its effects on other complications, such as retinopathy. “As we follow the participants in the REMOVAL trial, we will be able to gather key information that could help physicians determine which patients with type 1 might benefit from this combined therapy,” says Dr. Petrie.
Cardiovascular disease (mainly heart attack and stroke) is one of the leading causes of death resulting from diabetes—even with the best T1D management.
Aaron Kowalski, Ph.D., JDRF assistant vice president of treatment therapies, says research such as the REMOVAL study is urgently needed. “Cardiovascular complications are very real dangers for many people with this disease. Better therapies could not only improve the health of people living with type 1 diabetes, but could also save lives.”
The REMOVAL study is recruiting 500 participants ages 40 and older in the United Kingdom, Canada, Australia, Denmark, and the Netherlands. It will also be supported in Canada and Australia by those governments and through the JDRF Canadian Clinical Trial Network (CCTN) and JDRF Australia’s Clinical Trials Network (CTN).
To learn more about the REMOVAL trial, please click here.