Company’s technology has the potential to transform the treatment
of Type 2 diabetes by reducing the amount of metformin needed to control
blood sugarCatalina Research Institute in Chino, Calif.
Medical Research South in Charleston, S.C.Meharry Medical College in Nashville, Tenn.Meridian Research in Savannah, Ga.Meridien Research in Tampa, Fla.Palm Beach Research in Palm Beach, Fla.Sterling Research in Cincinnati, Oh.
Vanderbilt Medical Center in Nashville, Tenn.
NASHVILLE, Tenn.--(BUSINESS WIRE)--
Biopharma, Inc., is initiating a clinical trial with a goal of
demonstrating whether the company’s patented
technology may enhance the ability of a common Type 2 diabetes
medication, metformin, to control blood sugar. The primary design of
this Phase 2A trial is to test whether the combination of NuSirt
technology and three different low doses of metformin can effectively
control glucose levels when compared with full doses of metformin alone.
In this trial, NuSirt’s technology employs a patented blend of leucine,
an essential amino acid, coupled with an existing pharmaceutical
“Metformin is the most commonly prescribed oral medication to help those
with Type 2 diabetes control their blood sugar. However, the side
effects of metformin have been reported to cause people to not take it
as frequently as their doctors suggest or stop taking it altogether,”
C. Cook, Jr., president and executive chairman of the board of
NuSirt Biopharma. “We are hopeful that this trial will demonstrate that
NuSirt’s technology can be used with significantly lower doses of
metformin and maintain satisfactory blood sugar levels. A new diabetes
medicine that incorporates lower doses of metformin may reduce side
effects and help patients take the medication as prescribed.”
reported at the American Diabetes Association’s 74th
Scientific Sessions held in San Francisco this year, animal studies have
shown that NuSirt’s technology can amplify metformin’s effectiveness
while reducing its required dosage, contributing to substantial
improvement in glucose control and a reduction in fatty deposits in the
liver. The clinical trial now underway is designed to examine the
effects of this patented combination in humans.
Diabetes is the seventh leading cause of death in the U.S., and its
complications include blindness, kidney failure and peripheral
amputation. According to the American Diabetes Association, more than 29
million Americans have diabetes, and an additional 86 million Americans
age 20 and older have prediabetes.
“We believe the key to helping those with Type 2 diabetes better manage
their disease isn’t the development of new drugs, but finding ways to
encourage more effective use of medicines that already exist,” said Michael
Zemel, Ph.D., founder and chief scientific officer of NuSirt
Biopharma. “If we are able to reduce metformin’s side effects and
strengthen its effectiveness, NuSirt technology has the potential to
help establish a new approach to treating Type 2 diabetes.”
NuSirt’s Phase 2A trial is a randomized, double-blind, active controlled
study with an enrollment goal of more than 100 subjects who have Type 2
diabetes. The study will contain four different treatment arms, three of
which will incorporate NuSirt technology in combination with much lower
doses of metformin. The fourth arm will receive full label doses of
metformin alone, and follow standard clinical guidelines.
During the course of the study, participants will wear a blood sugar
monitoring device and measure their blood glucose frequently.
The primary objective of the trial is to evaluate the change in fasting
plasma glucose from baseline to the end of the 28 day study period.
Secondary objectives are to evaluate changes in fasting plasma insulin
and lipid levels, changes in glucose profiles, and effects on
The NuSirt trial is being conducted at eight sites across the U.S.:
Initial results from this Phase 2A study are expected by year end. If
the trial is successful, NuSirt’s current business plan calls for
initiating a Phase 2B study with an enrollment goal of approximately 500
participants who will be monitored over a six-month period.
For more information about the trial, contact firstname.lastname@example.org.
About NuSirt Biopharma, Inc.
NuSirt Biopharma, Inc., headquartered in Nashville, is dedicated to
improving the lives of people living with chronic diseases associated
with obesity and aging. The company has a unique technology platform
that uses a patented combination of leucine, an essential amino acid,
and existing human medicines targeted at diseases that may be addressed
by activating sirtuin pathways. These combinations have shown promise in
preventing and treating metabolic diseases and enhancing the
effectiveness of existing pharmaceuticals. For more information, please
Seigenthaler Public Relations
Nicole Cottrill, 615-327-7999
Source: NuSirt Biopharma, Inc.