Clinical Trial Seeks to Reduce Cardiovascular Risk in Adults with Type 1 Diabetes

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Mar. 05, 2012

JDRF-funded researchers in London begin enrollment for the REMOVAL study, to test whether metformin would help reduce or prevent common complications associated with type 1 diabetes.

JDRF-funded researchers are currently enrolling adult patients with type 1 diabetes (T1D) in Canada for the REMOVAL (Reducing with MetfOrmin Vascular Adverse Lesions in T1D) study. The study will test whether metformin – a drug commonly used to treat type 2 diabetes which has been shown to reduce cardiovascular events – could help prevent or reduce the risk of cardiovascular complications in people with T1D.

The REMOVAL study is a collaboration among JDRF, the University of Glasgow, and 17 sites across Canada, the United Kingdom, Australia, Denmark, and the Netherlands that will collectively enroll 500 patients. In Canada, St. Joseph’s Health Care (St. Joseph’s) in London and the University of Ottawa, both in Ontario, will serve as study sites for the trial.

REMOVAL will study 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 study will follow patients for three years, and will monitor the thickness of arteries in the neck, using ultrasound. This measurement is a marker that is used to predict the risk of future heart attacks and strokes. In the study, metformin or a placebo will be added to the regular insulin therapy of the participating patients. 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 for people with type 2 diabetes to help control blood glucose levels.

The REMOVAL 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. The study will be supported in Canada and Australia by the Canadian and Australian governments through JDRF Canadian Clinical Trial Network (JDRF CCTN) and the JDRF Australian Clinical Research Network (CRN), respectively. In Canada, the trial will be led by Dr. Irene Hramiak, Chief, Centre for Diabetes, Endocrinology and Metabolism of St. Joseph’s Health Care London, and Chair, Division of Endocrinology and Metabolism at Western University in London, Ontario. A second site is being led by Dr. T.C. Ooi, Director of Clinical Research, Division of Endocrinology and Metabolism, The Ottawa Hospital (Riverside Campus), and Professor of Medicine, University of Ottawa.

"Participating in clinical research gives patients an opportunity to contribute to new knowledge and innovation that will change their health," said Dr. Hramiak.

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 more than 300,000 Canadians 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 committed to improving the lives of every person affected by type 1 diabetes. An important part of that commitment is the discovery, development, and delivery of therapies for diabetes complications,” said Andrew McKee, President and CEO of JDRF CCTN. “For many of those living with this disease, cardiovascular complications are very real dangers. That is why research, like the REMOVAL study, is so urgently needed. The development of better therapies could not only improve the health and quality of life for people living with type 1 diabetes – it could save lives.”

"Our government’s support to JDRF will lead to a better life for all Canadians affected by diabetes,” said Joe Preston, Member of Parliament, Elgin-Middlesex-London, on behalf of the Honourable Gary Goodyear, Minister of State for the Federal Economic Development Agency for Southern Ontario (FedDev Ontario). “We know how hard all of the researchers work towards meaningful discoveries, and what life-changing effects they can have on patients and their families."

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 Health Canada for type 2 diabetes in 1971, and by the U.S. Food and Drug Administration (FDA) 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 Canada and 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.

About JDRF
JDRF is the leading global organization focused on 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 all people 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 per cent of JDRF's expenditures directly support research and research-related education.

About JDRF Canadian Clinical Trial Network
Created in partnership with the Government of Canada, funding for JDRF CCTN came from a commitment of $20 million by FedDev Ontario, with an additional $13.9 million contribution from JDRF. The $33.9 million investment will help accelerate the testing of new technologies and treatments for Canadians and individuals around the world living with T1D and its complications.

JDRF CCTN is a groundbreaking effort to accelerate solutions for the management, care and cure of T1D. JDRF CCTN is currently developing several high-profile clinical trials, in association with leading diabetes researchers at partner universities and medical centers in southern Ontario. The goal is to position southern Ontario as an international hub for diabetes translational research, innovation, and commercialization of new therapeutics and enabling technologies.

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For more information on REMOVAL, or to schedule an interview, please contact:
Jennifer Dolan
JDRF Canadian Clinical Trial Network
647-789-2012
jdolan@jdrf.ca

References
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.

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