JDRF initiates enrollment in metformin clinical study for type 1 diabetes

REMOVAL, a multi-site, international trial will test whether metformin helps prevent the development of a common complication associated with Type 1 diabetes

JDRF-funded researchers have begun enrolling adult patients with type 1 diabetes (T1D) in the REMOVAL study, to test whether metformin-a drug commonly used to treat type 2 diabetes-could help prevent or reduce the risk of cardiovascular complications in people with T1D.

The REMOVAL study (Reducing with MetfOrmin Vascular Adverse Lesions in T1D) is a multi-center, international trial that will study 500 patients with T1D aged 40 or older, a patient group known to be at higher risk for cardiovascular disease, one of the leading causes of death associated with diabetes. A study from the United Kingdom has shown that people with T1D aged over 40 are at much higher risk for cardiovascular disease, including heart attack and stroke.

The REMOVAL study will follow patients for five years. In the study, metformin or a placebo will be added to regular insulin therapy. The study will also test the drug's effects on the control of diabetes and treatment satisfaction, as well as its effects on other complications, such as diabetic eye disease. Metformin has a proven safety record based on over 50 years of use in people with type 2 diabetes to help control blood glucose levels.

The study is being led by Professor John Petrie from the University of Glasgow, United Kingdom (primary investigator) and Professor Helen Colhoun from the University of Dundee, United Kingdom, and is recruiting participants in five countries: the United Kingdom, Canada, Australia, Denmark, and the Netherlands. The REMOVAL study will be supported in Canada and Australia by the Canadian and Australian governments through the JDRF Canadian Clinical Trial Network (CCTN) and the JDRF Australian Clinical Trial Network (CTN), respectively.

"Given what we know about metformin, we are eager to learn whether its benefits, when added to insulin therapy, could have a positive impact on the health and lives of people with type 1 diabetes who are at risk for cardiovascular problems," said Dr. Petrie. "As we follow the participants in the REMOVAL trial, we will be able to gather key information that could help physicians understand whether this patient population might benefit from this combined therapy."

JDRF, the leading charitable funder of T1D research worldwide, is supporting the REMOVAL study as part of its efforts to discover and develop treatments for the devastating complications that can arise from T1D-an autoimmune disease that affects as many as 3 million Americans and has no known cause or cure. It is one of the largest trials ever funded by JDRF targeted at reducing the complications of T1D.

"JDRF is dedicated to people with type 1 diabetes, and an important part of that commitment involves the discovery and development of therapies for diabetes complications," said Aaron Kowalski, assistant vice president of treatment therapies for JDRF. "Cardiovascular complications are very real dangers for many people with this disease, which is why research like the REMOVAL study is urgently needed. Better therapies could not only improve the health of people living with type 1, but could save lives."