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