REMOVAL, a multi-site, international trial will test whether metformin helps prevent the development of a common complication associated with type 1 diabetes
New York, NY, December 13, 2011-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. [1]
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 Research Network (CRN), 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."
To learn more about the REMOVAL trial, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01483560
About metformin
Metformin is an oral, widely-prescribed first-line drug for type 2 diabetes, and is available in generic forms in several countries. It has been on the market in some European countries for more than 50 years. It was approved by the U.S. Food and Drug Administration (FDA) for type 2 diabetes in 1994. Metformin works by preventing high blood sugar, but evidence also exists that it can improve blood vessel function, reduce risk factors for cardiovascular disease, and improve the action of insulin on the liver, even for people without diabetes. These potentially beneficial properties could also reduce risk in T1D. In fact, metformin has already been approved for use in T1D in France and Portugal. Approval in the United States would require evidence that metformin not only reduces cardiovascular risk, but could prevent heart attacks and/or strokes. REMOVAL is a necessary gateway trial into this more extensive research.
About T1D
In T1D, a person's pancreas stops producing enough insulin to survive. People with T1D must currently monitor their blood sugar levels and administer insulin via shots or an insulin pump, multiple times every day. Even vigilant management does not ward against T1D complications such as heart attack, stroke, blindness, and amputation.
[1] Soedamah-Muthu, Sabita S., John H. Fuller, Henrietta E. Mulnier, Veena S. Raleigh, Ross A. Lawrenson, and Helen M. Colhoun. "High Risk of Cardiovascular Disease in Patients With Type 1 Diabetes in the U.K.: A cohort study using the General Practice Research Database." Diabetes Care 29.4 (April 2006): 798-804.
About JDRF
JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is now the largest charitable supporter of T1D research. The goal of JDRF research is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal.
Since its founding in 1970, JDRF has awarded more than $1.6 billion to diabetes research. Past JDRF efforts have helped to significantly advance the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. More than 80 percent of JDRF's expenditures directly support research and research-related education.
For more information, please visit www.jdrf.org.
