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June 10, 2002: Canadian Institutes of Health
Research Press Release
MINISTER MCLELLAN LAUNCHES LARGEST PEDIATRIC CLINICAL
TRIAL IN CANADA / CANADA TO PROVIDE $10 MILLION TO PREVENT
OF TYPE I DIABETES IN ITS EARLIEST BEGINNINGS
For immediate release 2002-18
TORONTO (June 10, 2002) - The Honourable Anne McLellan,
Minister of Health and Dr. Alan Bernstein, President
of the Canadian Institutes of Health Research launched
today at The Hospital for Sick Children (HSC) the Canadian
component of a multinational clinical trial aimed at
reducing the incidence of Type 1 diabetes in children.
Type 1 diabetes, usually diagnosed in children, is
due to abnormal autoimmunity that destroys insulin producing
cells in the pancreas. Insulin is an essential hormone
that regulates energy production from sugar and fat.
Approximately 200,000 Canadians have Type I diabetes
and require daily insulin injections. Type 1 diabetes
hardens small blood vessels and is the leading cause
of blindness, heart and kidney disease, stroke and loss
TRIGR (Trial to Reduce Insulin-Dependent Diabetes in
the Genetically at Risk) is the largest clinical trial
ever conducted in Canada and one of the largest pediatric
trials in the world. Based out of the Robarts Research
Institute in London, Ontario, this trial will determine
if delaying dietary exposure to intact foreign food
proteins can reduce the risk of developing Type 1 diabetes
in children who are genetically predisposed to the disease.
The total budget for this 10-year study will exceed
$50 million of which the Canadian component includes
$10 million from CIHR and a significant contribution
from the Juvenile Diabetes Research Foundation. Other
funders include the US National Institutes of Health
and several European agencies. The Mead-Johnson Division
of Bristol-Myers-Squibb, Evansville, Illinois supported
the development of the TRIGR trial from its inception
to the present trial, and supplies all formulas worldwide.
The Hospital for Sick Children Foundation provided grants
to support the national and international trial development.
"The potential outcome of this clinical trial
is extraordinary in terms of improving the health of
our children, reducing the burden of illness in our
health care system and advancing global health,"
said Minister McLellan. "One of the most effective
ways to reduce the incidence of diseases such as diabetes
is to focus on preventative measures such as this trial
which offers great hope for those suffering from diabetes."
"We are entering a science-based age in health
research and health care. The TRIGR trial is the first
concerted scientific effort to tackle diabetes with
a practical, primary prevention measure," said
Dr. Bernstein. "This clinical trial is a shining
example of applying science in the real world -- a major
priority of CIHR."
Approximately 6000 families with a history of Type
1 diabetes and expecting a baby will be recruited for
this study. When babies are weaned from breastfeeding,
they will receive infant formulas that contain no, or
a reduced amount of, intact foreign food proteins typically
found in baby formulas. TRIGR will enroll babies from
across 17 countries. Recruitment will span two years,
with follow-up for 10 years.
Over 40 centres in Canada, the United States, Europe
and Australia will be involved in TRIGR. The coordinating
centre for this international study is in Finland, led
by Dr. Hans K. Åkerblom. The 14 Canadian centres
involved in the trials are: Calgary, Edmonton, Halifax/PEI,
London, Montreal, Ottawa/Kingston, Quebec City, Saint
John, St. John's, Toronto, Vancouver, Winnipeg/Saskatoon.
The national study will be led by Dr. John Dupré
(Robarts Research Institute) with Dr. Michael Dosch
(The Hospital for Sick Children), Dr. William Fraser
(Université Laval), Dr. Margaret Lawson (Children's
Hospital of Eastern Ontario), Dr. Jeffery Mahon (University
of Western Ontario) and Dr. Shayne P. Taback (University
of Manitoba), and an additional 34 Canadian investigators
at the clinical centres.
"This is the first trial that attempts to prevent
the development of diabetes in its earliest beginnings,"
said Dr. John Dupré, co-principal investigator
of the Canadian study. "TRIGR is an excellent example
of bench-to-bedside research. Substantial evidence from
basic laboratory research, and animal and human pilot
studies, helped to develop this trial over the past
This clinical trial builds on basic research that began
at Toronto's Hospital for Sick Children in the 1980s.
"It appears that the immune system in young infants
with genetic diabetes risk is less mature and unable
to normally handle intact foreign food proteins. This
sets up a chain reaction that can lead to autoimmune
destruction of insulin-producing cells. Our study formula
does not contain such proteins and gives the immune
system time to catch up in development," said Dr.
Michael Dosch, the basic science chair of TRIGR, co-principal
investigator of the Canadian study, and a senior scientist
"This international effort will investigate potential
environmental factors that affect people at risk of
developing Type-1 diabetes," said Ron Forbes, President
& CEO of the Juvenile Diabetes Research Foundation.
"Regardless of the study's outcome, the collaborations
fostered in this study should prove immensely valuable
in future efforts to prevent Type 1 diabetes."
CIHR is Canada's premier agency for funding health
research. Its objective is to excel, according to internationally
accepted standards of scientific excellence, in the
creation of new knowledge and its translation into improved
health for Canadians, more effective health services
and products, and a strengthened health care system.
For more information on enrolling in TRIGR, call 1-888-STOP-T1D
or visit the TRIGR website at www.trigr.org.
Janet Weichel, CIHR Communications, (613) 447-4794
Laura Greer, The Hospital for Sick Children, (416) 813-5046
Farah Mohamed, Minister McLellan's Office (613) 957-0200
Ce document est également disponible en français.