C-peptide, a biomarker that indicates insulin
production, is a validated surrogate endpoint in type 1 diabetes
clinical trials
NEW
YORK, May 20, 2024 /PRNewswire/ -- A paper
published in the June edition of the Journal Diabetes
demonstrates that C-peptide, a biomarker that indicates the
production of insulin, is a validated surrogate endpoint, or
predictor of clinical benefit, for clinical trials of
disease-modifying therapies for type 1 diabetes (T1D) in the
new-onset stage. The paper, written by JDRF Vice President of
Research Esther Latres, Ph.D., and co-authored by JDRF staff and
other leaders in the field, reviewed published evidence and clearly
demonstrated the association between the preservation of C-peptide
and clinical benefits. If accepted by the regulators, the use of
C-peptide as a validated endpoint has the potential to transform
T1D clinical trials and accelerate the development of
disease-modifying therapies for T1D.
"Through a comprehensive and extensive review of studies showing
clinical benefits and endpoints traditionally used in type 1
diabetes, there is support for the acceptance of stimulated
C-peptide as a validated surrogate endpoint for clinical trials in
disease-modifying therapies in people with newly diagnosed type 1
diabetes," said Esther Latres, JDRF Vice President of Research.
"There remains an urgent need for new therapies that can change the
course of T1D, particularly in its early stages. Such acceptance
would be a breakthrough that could rapidly advance the development
of life-changing therapies and lead the way to cures for type 1
diabetes."
Decades of research have resulted in tremendous progress and
therapeutic options to improve T1D, yet there is still a
significant unmet need to improve outcomes for those who live with
the condition. The authors highlight the role and importance of
disease-modifying therapies in addressing this need. However, the
currently accepted efficacy endpoints, HbA1c, low blood sugar
events, and complications, are limiting for disease-modifying
therapy clinical trials, particularly in new-onset T1D, where low
blood sugar events are uncommon and complications take years to
develop.
"Disease-modifying therapies are a key element of JDRF's
research strategy to develop cures for type 1 diabetes," said
Sanjoy Dutta, Ph.D., co-author and
JDRF Chief Scientific Officer. "The research in this area is
promising, with the approval of the first disease-modifying therapy
for people in Stage 2 T1D, teplizumab, in 2022. Importantly,
several drugs approved for other autoimmune diseases have shown
they can protect and preserve C-peptide at the time of diagnosis,
and it's JDRF's role to help accelerate the development pathway for
disease-modifying therapies in T1D."
About JDRF
JDRF's mission is to accelerate life-changing breakthroughs to
cure, prevent, and treat T1D and its complications. To accomplish
this, JDRF has invested more than $2.5
billion in research funding since our inception. We are an
organization built on a grassroots model of people connecting in
their local communities, collaborating regionally and globally for
efficiency and broader fundraising impact, and uniting on a global
stage to pool resources, passion, and energy. We collaborate with
academic institutions, policymakers, and corporate and industry
partners to develop and deliver a pipeline of innovative therapies
to people living with T1D. Our staff and volunteers throughout
the United States and our five
international affiliates are dedicated to advocacy, community
engagement, and our vision of a world without T1D. For more
information, please visit jdrf.org or follow us on Twitter (@JDRF),
Facebook (@myjdrf), and Instagram (@jdrfhq).
About Type 1 Diabetes (T1D)
T1D is an autoimmune condition that causes the pancreas to
make very little insulin or none at all. This leads to
dependence on insulin therapy and the risk of short or long-term
complications, which can include highs and lows in blood sugar;
damage to the kidneys, eyes, nerves, and heart; and even death if
left untreated. Globally, it impacts nearly 9 million people. Many
believe T1D is only diagnosed in childhood and adolescence, but
diagnosis in adulthood is common and accounts for nearly 50% of all
T1D diagnoses. The onset of T1D has nothing to do with diet or
lifestyle. While its causes are not yet entirely understood,
scientists believe that both genetic factors and environmental
triggers are involved. There is currently no cure for T1D.
Media Contact:
Casey Fielder
media@jdrf.org
509-651-0087
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SOURCE JDRF International