£430,000 study to test new drug preventing heart disease in diabetics
20 Dec 2011
A drug that removes excess copper from people with diabetes resulting in improved function of the heart is to be tested in a national trial led by researchers in Manchester.
The research team has received funding of £430,000 for the phase 2B trial from the J P Moulton Charitable Foundation, set up by entrepreneur Jon Moulton to fund non-commercial clinical trials.
Professor Paul Bishop, from The University of Manchester's School of Biomedicine, will lead the trial, working with colleagues at the Centre for Advanced Discovery and Experimental Therapeutics (CADET), based at Manchester Royal Infirmary (MRI).
Initial studies have shown that the drug trientine, which only costs a few pence per tablet to produce, can prevent major diabetes-related complications. In patients with diabetes, excess copper accumulates in the tissues and the Manchester team has already shown that this leads to damage in the heart. Trientine sticks to the excess copper and allows it to be safely removed from the body, preventing further damage and even allowing damaged heart muscle to regenerate.
Around 240 patients with type-2 diabetes will participate at MRI, Salford Royal Hospital, the University Hospital of South Manchester and St Thomas’ Hospital in London. The patients will be recruited over 18 months, beginning in early 2012, and each participant will be monitored over 18 months to check their response to the drug.
The trial is supported by the National Institute for Health Research Manchester Biomedical Research Centre. The Central Manchester University Hospitals NHS Foundation Trust Charity has funded the purchase of equipment for measuring levels of copper in the blood and urine.
“CADET colleague Professor Garth Cooper has already done studies in a few patients and got some very good results,” said Professor Bishop. “The next step is to look more widely at the effects of the drug in this new study and measure the response in a larger number of patients. We think that trientine has the potential to be much more effective than any other drug for treating heart complications in people with diabetes.
“Once this study is completed, we hope that we will have sufficient data to justify proceeding to a very large scale, or phase 3, clinical trial.
“We expect it will take around six to eight years to get the drug fully approved for global use. By 2020, it is estimated that there will be around 300 million people with diabetes worldwide, and it is quite possible that many of them would benefit from treatment with this drug”.
Notes for editors
A phase 2B trial is a multi-centre trial (typically involving 100-300 patients) designed to investigate how well a drug works. A phase 3 trial is larger than a phase 2 trial (typically 300-3000 patients) and is regarded as the definitive investigation into how well the drug works.
The NIHR Manchester Biomedical Research Centre was created by the National Institute for Health Research in 2008 to effectively move scientific breakthroughs from the laboratory, through clinical trials and into practice within hospitals to improve patient care. As a partnership between Central Manchester University Hospitals NHS Foundation Trust and The University of Manchester, the Biomedical Research Centre is designated as a specialist centre of excellence in genetics and developmental medicine. www.manchesterbrc.org
The University of Manchester, a member of the Russell Group, is one of the most popular universities in the UK. It has 22 academic schools and hundreds of specialist research groups undertaking pioneering multi-disciplinary teaching and research of worldwide significance. According to the results of the 2008 Research Assessment Exercise, The University of Manchester is now one of the country’s major research universities, rated third in the UK in terms of ‘research power’. The University had an annual income of £788 million in 2009/10.
Central Manchester University Hospitals NHS Foundation Trust is a leading provider of specialist healthcare services in Manchester, treating more than a million patients every year. Its five specialist hospitals (Manchester Royal Infirmary, Saint Mary’s Hospital, Royal Manchester Children’s Hospital, Manchester Royal Eye Hospital and the University Dental Hospital of Manchester) are home to hundreds of world class clinicians and academic staff committed to finding patients the best care and treatments. www.cmft.nhs.uk
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