FALLS, S.D. –
The results of The
Sanford Project’s first clinical trial are published in the July edition
Lancet Diabetes & Endocrinology, revealing the outcome of a two-year
study exploring the benefits of two drugs in treating type 1 diabetes.
is titled “Combination therapy with sitagliptin and lansoprazole in
patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of
a multicentre, randomised, placebo-controlled, phase 2 trial.”
The Sanford Project is an emerging translational research center focused on
targeted diabetes research, cures and care made possible in part through the
generosity of Denny Sanford and Todd and Linda Broin.
In August 2012, The Sanford Project Todd and Linda Broin Chair Alex
Rabinovitch, M.D., and his team announced they had reached full patient
enrollment for Restore Pancreatic Insulin Response in type 1 diabetes
(REPAIR-T1D). Based on a successful mouse model, the study explored if
two FDA-approved drugs, sitagliptin and lansoprazole, could regenerate beta
cells in humans by improving levels of GLP-1 and gastrin hormones. Type 1
diabetics experience a loss of insulin-producing beta cells and need to
inject insulin into their bodies manually.
Sixty-nine participants between the ages of 11 and 36 received either the two
drugs or a placebo while continuing their insulin injections. The group
receiving the drugs did not experience an improvement in insulin production,
but some study participants whose GLP-1 and gastrin levels increased may have
better preserved beta cell levels.
“While the results of our first clinical trial did not indicate a
regeneration of beta cells as a result of the drugs used, it is promising
that some of the participants seemed to have preserved beta cells that may
have otherwise died,” said Rabinovitch. “The next step is to design another
study based on what we learned from the REPAIR trial and continue to make
progress towards a cure.”
Rabinovitch is finalizing plans for the next clinical trial involving
participants from the REPAIR-TID project to better understand why responses
to the sitagliptin and lansoprazole differed among participants.
“What is perhaps most remarkable about the completion of this trial is the
pace in which we are able to conduct research here at Sanford because of our
size and strategic investments in people and infrastructure,” said David
Pearce, Ph.D., vice president and chief operating officer for Sanford
Research. “The results have left The Sanford Project team both anxious and
prepared to learn more about why patients reacted differently to the two
drugs that were utilized in this clinical trial.”
The REPAIR-T1D trial was funded by Sanford
Research and JDRF.
“Curing T1D is challenging because of the complexity of the disease and the
differences among the people who are diagnosed with it” said JDRF director
and program lead Patricia Kilian, Ph.D. “The REPAIR-T1D study was an
important translational effort; testing what was a promising approach in
animals in a well-executed study with people. The results represent
another step on the path towards improving beta cell function for people with
T1D and our ultimate goal of finding a cure for the disease.”
JDRF has a strategic T1D research plan with a strong emphasis on
translational development designed to deliver a sustained stream of new,
life-changing therapies to people with this disease. This study was
supported in part by JDRF as part of its restoration research program, the
goal of which is to restore the body’s beta cell function and halt the
autoimmune attack – in short, the biological cure for type 1 diabetes.
Sanford Research is a
non-profit research organization and is part of Sanford Health, an integrated
health system headquartered in the Dakotas. Sanford represents the largest,
rural, not-for-profit health care system in the nation with a presence in 111
communities, nine states and two countries. In 2007, a transformational gift
of $400 million by Denny Sanford provided for an expansion of children’s and
research initiatives, one of which was to find a cure for type 1 diabetes,
and has given Sanford Research significant momentum in its goal of becoming
one of the premiere research institutions in the United States and the world.
Most recently, subsequent gifts of more than $200 million by Mr. Sanford have
paved the way to establish Edith Sanford Breast Cancer Research and Sanford
With a team of more than 200 researchers, Sanford Research comprises several
research centers, including Children’s Health Research, Edith Sanford Breast
Cancer, Cancer Biology, Center for Health Outcomes and Prevention and Sanford
Sports Science Institute.