posted on Nov. 1: McMaster research team will receive $25 million for diabetes study

Diabetes research will receive a $25-million boost today with an announcement at McMaster of funding for an international clinical trial in the prevention of the disease.

The research study will be headed by McMaster University researchers Hertzel Gerstein, associate professor of medicine and director, division of endocrinology and metabolism, and Salim Yusuf, professor of medicine, director, division of cardiology and director, Population Health Institute.

Alan Bernstein, president of the Canadian Institutes of Health Research (CIHR); Jefferson Gregory, president & COO, King Pharmaceuticals Inc, U.S.A. ; Jean-Frangois Leprince, president, Aventis Pharma Inc. of Canada; David Stout, President Pharmaceuticals, North America, SmithKline Beecham; and Roger White, medical director, Smith Kline Beecham Canada announced the funding at a press conference on campus Wednesday.

The study will test the possibility that the drugs ramipril and/or rosiglitazone can prevent Type 2 diabetes and involve a team of researchers from across Canada, the U.S. and Europe.

The DREAM study (Diabetes Reduction Approaches with ramipril and rosiglitazone Medications) will examine the effects of the drugs over a five-and-a-half year period. The project will be funded by King Pharmaceuticals, Aventis Pharma and SmithKline Beecham, in collaboration with CIHR through both its CIHR/Rx&D Research and Clinical Trials Programs.

The application received the highest peer-reviewed ranking of any new CIHR clinical trial application in over 10 years. The DREAM study will follow 4,000 individuals at high risk of developing diabetes because of impaired glucose tolerance. Subjects in the study will be randomly allocated to ramipril or a placebo and rosiglitazone or placebo, and followed up every six months for glucose intolerance and the development of new diabetes cases.

“This is an outstanding example of the important health research taking place here in Canada,” says Bernstein. “Breakthroughs that have resulted from academia-industry collaboration mean better treatments and cures, the possible prevention of heart disease and diabetes, better health for Canadians and people around the world and significant savings to our health care system.”

The DREAM trial follows Yusuf's internationally recognized CIHR/Rx&D funded HOPE study (Heart Outcomes Prevention Evaluation), which concluded last year that the use of the ACE inhibitor ramipril substantially improves the survival rate in high risk patients as well as lowering the risk of subsequent heart attacks and strokes. In addition to these findings, researchers unexpectedly observed that ramipril also reduced self-reported cases of diabetes by 34 per cent.

However, as the study was tailored to examine the effects of ramipril in preventing heart attacks, it did not objectively test the possibility that the drug might also prevent diabetes.

Rosiglitazone is a leading agent that has been widely prescribed in the USA and has been available in Canada since March 2000. It belongs to a new class of drugs called thiazolidinediones, or glitazones, that directly target insulin resistance, an underlying cause of type 2 diabetes. Additionally, preclinical data has proven that Avandia. regenerates beta cells in the pancreas which is critical to slowing the progression of Type 2 diabetes.

“The last few years have seen many new advances in our understanding of diabetes and our ability to treat it effectively,” says Gerstein. “Obviously the best way to prevent the serious health consequence of diabetes is to prevent diabetes from occurring in the first place — a possibility that will be tested in the DREAM study using two promising and exciting approaches.”

Recruitment will focus on populations with a particularly high diabetes risk, such as those individuals with close relatives who have diabetes or special groups prone to diabetes such as aboriginals and south Asians. If ramipril or rosiglitazone is shown to reduce diabetes, these therapies would be widely applicable and have a significant public health impact.

More than one in eight middle-aged adults have Type 2 diabetes, of whom about 30 per cent are undiagnosed. Affected people have an increased risk of blindness, renal failure, amputations, myocardial infarction and stroke.

The national DREAM trial research team also includes: Sonia Anand, Jackie Bosch, Sarah Capes, Eva Lonn, Matthew McQueen and Koon Teo at McMaster University; Jean-Louis Chiasson at the Centre hospitalier universitaire de l'Universiti de Montrial (CHUM) Research Centre; Gilles Dagenais at Laval University; Edmond Ryan at the Heritage Medical Research Centre in Edmonton; and Bernard Zinman at the University of Toronto and Mount Sinai Hospital.

The CIHR/Rx&D Research Program is a jointly funded program that fosters productive and effective partnerships between academic health researchers and the pharmaceutical industry and supports the training and development of health research personnel and opportunities in Canada.