Joslin
launches National Clinical Trial to explore
if Anti-Inflammatory Drug can improve
Glucose Control in Type 2 Diabetes
Newswise — Joslin Diabetes Center scientists
are taking groundbreaking research on the
role of inflammation in type 2 diabetes to a
new level with the launch of a national
clinical trial to investigate whether
salsalate, an anti-inflammatory drug used
for years to manage arthritis pain, can
reduce blood glucose levels in people with
type 2 diabetes.
If successful, the trial could lead one day
to an inexpensive way to treat this most
common form of diabetes, which has been
increasing at epidemic rates in recent
years.
About 560 adults with poorly controlled
blood glucose levels are being sought to
participate for one year in a clinical
research study, referred to as Targeting
Inflammation with Salsalate in Type 2
Diabetes (TINSAL-T2D).
The study is being funded by the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), part of the
National Institutes of Health.
The study will be conducted at Joslin in
Boston and at 20 other medical institutions
across the nation.
Initial studies by the Joslin group showed
that salsalate was effective to lower blood
glucose when given for 3 months, leading to
the start of this larger trial of longer
duration.
“These are very important studies aimed to
test whether reducing inflammation can
actually be used to treat diabetes,” says
principal investigator Steven E. Shoelson,
M.D., Ph.D., the Helen and Morton Adler
Chair and Associate Director of Research at
Joslin Diabetes Center and Professor of
Medicine at Harvard Medical School.
“Given what we are learning about how type 2
diabetes develops, we think this might be
getting at an underlying cause. We hope the
study shows that targeting inflammation is a
safe and inexpensive way to treat type 2
diabetes.
"We
also hope that reducing inflammation
decreases risk for coronary heart disease,
which is another theory that we will be
testing in a separate clinical study in the
coming months.”
In the United States, nearly 24 million
people have diabetes. Type 2 diabetes
accounts for about 90 to 95 percent of
diagnosed cases, representing nearly 10
percent of the adult population.
Type 2 diabetes, previously called adult
onset or non-insulin dependent diabetes, is
a disorder in which muscle and fat cells do
not use insulin properly.
Type 2 diabetes is closely linked to obesity
and puts people who have the disease at
greater risk for complications, including
cardiovascular disease, blindness, kidney
disease and amputations.
People with type 2 diabetes die at rates
two- to four-times higher than those who do
not have diabetes.
“Sedentary lifestyle and western diet have
been associated with obesity and diabetes,”
says co-principal investigator Allison B.
Goldfine, M.D., Director of Clinical
Research at Joslin and Associate Professor
of Medicine at Harvard Medical School.
“The study medication, salsalate, which is
chemically similar to aspirin but has fewer
side effects, has been used for more than 40
years in people to treat pain associated
with arthritis.
"Recent
studies in people show that salsalate also
lowers blood glucose, but further testing on
long-term efficacy and safety specifically
in patients with diabetes needs to be done.”
“The outcome of this study has the potential
for significant public health benefit,” said
Myrlene Staten, M.D., NIDDK’s Senior Advisor
for Diabetes Translational Research.
“If salsalate improves the control of type 2
diabetes, we would have an inexpensive
addition to our arsenal of drug options.”
In previous studies Drs. Shoelson and
Goldfine and their collaborators found that
inflammation – an immune system response
that normally fights infection and promotes
healing – plays a major role in the
development of insulin resistance and type 2
diabetes.
These researchers were the first to show
that a major trigger of inflammation – the
transcription factor NF-kB – is activated in
fat, liver, and other tissues of the body,
perhaps providing the “missing link” between
obesity and diabetes.
In a real bench-to-bedside victory, the
researchers built on these discoveries by
conducting clinical trials in patients with
diabetes, testing anti-inflammatory
salicylates, which inhibit NF-kB, as insulin
sensitizers.
In these patients, blood glucose and lipid
levels substantially decreased, glucose
uptake and utilization improved, and liver
glucose production decreased.
These findings of improved glycemia were
recently confirmed when the drug was given
for three months to patients with type 2
diabetes, laying the groundwork for the new
clinical trial.
For the TINSAL-T2D study, the researchers
are seeking adults ages 18 to 75 whose
glucose levels are not in good control and
who do not take insulin.
Participants
must be using no medication or be taking
only one or two oral medications, among
other criteria. Most participants can expect
their involvement to last about one year.
Those volunteering to participate in the
TINSAL-T2D study will undergo a variety of
tests to determine if they are eligible.
Participants selected for the study may
receive either the study drug or a placebo.
A placebo is an inactive pill that looks
like the study drug, but a placebo contains
no active medication.
Placebos are used to determine if the
results of the study are truly from the
study drug. TINSAL-T2D study participants
will receive all medication and treatments
related to the study free of charge, and
will continue to see their personal
physician for all of their healthcare needs.
About Joslin Diabetes
Center
Joslin Diabetes Center is the world’s
preeminent diabetes research and clinical
care organization.
Joslin is dedicated to ensuring people with
diabetes live long, healthy lives and offers
real hope and progress toward diabetes
prevention and a cure for the disease.
Founded in 1898 by Elliott P. Joslin, M.D.,
Joslin is an independent nonprofit
institution affiliated with Harvard Medical
School. For more information about Joslin,
call 1-800-JOSLIN-1 or visit
www.joslin.org
.
