First patient recruited to major international diabetes trial
Doctors and scientists at the University of Glasgow have recruited the first patient to join a major international research project to reduce the risk of cardiovascular disease in people with type 1 diabetes (T1D).
The five-year, £4.25m trial, funded by the international T1D research charity JDRF and led by researchers at the Universities of Glasgow and Dundee, will study the effects of a drug called metformin on people aged 40 and over who have type 1 diabetes.
Cardiovascular disease is one of the leading causes of death associated with T1D. A U.K. study has shown that men in their 40s with T1D are three times more likely to develop cardiovascular disease than the general population, and the risk for diabetic women of the same age is fivefold. [i]
The trial, known as REMOVAL (Reducing with MetfOrmin Vascular Adverse Lesions in type 1 diabetes), will recruit 500 participants from the UK, Canada, Australia, Denmark and the Netherlands.
They will be given either metformin or a placebo in addition to their regular insulin therapy and researchers will monitor the effect on control of their diabetes as well as other common complications such as diabetic eye disease.
Professor John Petrie, Professor in Diabetic Medicine at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences, said: “We’re pleased to have recruited our first patient from Stobhill Hospital in Glasgow. We’re looking forward to recruiting 250 patients from across the UK in the coming months.
“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. Given what we already know about the drug, 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.
“REMOVAL will test whether three years of metformin added to insulin therapy reduces what is known as ‘intima-media thickness’, a thickening in the walls of the blood vessels which can be used as a measurement to predict the risk of future heart attacks and strokes.
“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.”
Public Health Minister Michael Matheson said: “This important international study is a great example of Scotland’s growing diabetes research capability.
“That this project is being led from Scotland reflects our commitment to supporting world class diabetes research that, in time, will help to improve the care and lives of people with the disease.”
JDRF, the largest charitable funder of T1D research is supporting the REMOVAL study as part of its efforts to discover and develop treatments for the devastating complications that can arise from the disease. T1D affects as many as 275,000 people in the UK and has no known cause or cure. REMOVAL is one of the largest trials ever funded by JDRF targeted at reducing the complications of T1D.
Rachel Connor, Head of Research Communication at JDRF UK said: ‘While research has helped people with type 1 diabetes and their doctors to improve their control over their glucose levels so that it is better than ever before, people affected by the disease are still at risk of devastating long term complications, such as cardiovascular disease. JDRF is searching for the cure for type 1 diabetes, but while we are doing so we are also investing in research to help people affected by type 1 diabetes to stay healthy for as long as possible. By working with the University of Glasgow on the REMOVAL trial, we hope to find a new way to use an existing medicine to protect people with type 1 diabetes.’
The REMOVAL study is coordinated by the Glasgow Clinical Trials Unit and led by Professor John Petrie from the University of Glasgow and Professor Helen Colhoun from the University of Dundee who work together as part of the Scottish Diabetes Research Network, a world leading nationwide collaboration on diabetes research funded by the Chief Scientist Office of the Scottish Government." The trial is co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde.
Carotid ultrasound scans will be read centrally at Imperial College, London and retinal photographs will be graded centrally at the University of Wisconsin. It is 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).
For more information on the REMOVAL trial, visit http://www.clinicaltrials.gov/ct2/show/NCT01483560
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. 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.
About type 1 diabetes (T1D)
- T1D is a chronic, life-threatening condition that has a life-long impact on those diagnosed with it and their families.
- T1D is an autoimmune condition which cannot be prevented, and is not caused by lifestyle factors such as diet and exercise
- People with T1D rely on multiple insulin injections or pump infusions every day just to stay alive, until we find the cure.
- T1D affects about 275,000 people in the UK, 26,000 of them are children.
- T1D reduces life expectancy by up to 20 years.
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 the largest charitable supporter of T1D research. The goal of JDRF 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 £900 million ($1.5 billion) to T1D research. More than 80 percent of JDRF's expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve 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. www.jdrf.org.uk
 Department of Health (2007). About diabetes
[i] Soedamah-Muthu, Sabita S., John H. Fuller, Henrietta E. Mulnier, Veena S. Raleigh, Ross A. Lawrenson, and Helen M. Calhoun. “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.
For more information contact Cara MacDowall in the University of Glasgow Media Relations Office on 0141 330 3683 or email email@example.com
First published: 13 December 2011