GI Dynamics Press Release 11-11-09
GI Dynamics' EndoBarrierTM Gastrointestinal Liner Demonstrates Significant HbA1c Reduction in Obese People Living with Type 2 Diabetes
Data
Published in Diabetes Technology and Therapeutics; EndoBarrier
Shown to Rapidly Improve Glycemic Control, Enhance Weight Loss
“Studies show that every one percent decrease in HbA1c reduces
health risks by 21 percent and as the rates of obesity and type 2
diabetes continue to reach epidemic proportions around the globe, patients are
in urgent need of new therapeutic solutions that overcome the limitations
associated with pharmaceutical regimens and invasive surgery,” stated Christopher
Sorli, M.D., F.A.C.E., Department of Endocrinology, Billings Clinic, Billings,
Montana and lead study author. “The results seen in the pilot study published
today are significant because they underscore the promise of EndoBarrier as a
non-surgical therapy that may offer immediate and sustained glycemic control in
patients most at risk for developing serious complications due to their diabetes.”
The trial was designed to evaluate the
EndoBarrier Gastrointestinal Liner for the treatment of type 2 diabetes; the
single-blind, long-term study was conducted in 18 patients with type 2 diabetes
who were prospectively randomized to receive either the EndoBarrier
Gastrointestinal Liner (n=12) or a sham endoscopy (n=6). The primary endpoint in
the trial was the reduction of HbA1c (average blood glucose level over three
months) in patients who had a baseline HbA1c of 9.1 percent and BMI (body mass
index) of 38.9.
Patients achieved the following
results over a 24-week period, during which the device was implanted:
- Patients
treated with EndoBarrier achieved a mean reduction of 2.4% in HbA1c
glucose levels versus 0.8% for the sham arm at 24 weeks;
- Patients
treated with EndoBarrier achieved a 55-point reduction in fasting blood
glucose levels, another key indicator of diabetic status, versus a 42-point
increase for the sham arm in one week;
- Patients
treated with EndoBarrier achieved a 20% decrease in the area under the
glucose curve during a meal tolerance test at week one compared to a 17%
increase in the sham arm.
Keith
Gersin, M.D., FACS, Chief of Bariatric Surgery at Carolinas Medical Center, stated, “In clinical studies conducted to date with the EndoBarrier,
patients have experienced immediate resolution of type 2 diabetes while the
EndoBarrier is implanted, and continued resolution of their diabetes after the
device is removed, as well as the important benefit of weight loss. These results
are similar to those seen with gastric bypass surgery; however the EndoBarrier
is implanted endoscopically during an incision-less, outpatient procedure. ”
GI
Dynamics is defining a new class of metabolic
treatment options that fit between pharmaceutical regimens and surgery, called
non-surgical therapeutics. Non-surgical therapeutics are designed to
eliminate or reduce the risks and side effects associated with pharmaceutical
regimens as well as surgical options. This new class of treatment can be performed
easily and quickly without any incisions, thus reducing patient anxiety and
recuperative time. Unlike traditional pharmaceutical approaches, non-surgical
therapeutics remove the burden of dose regimen compliance from the patient.
Additionally, non-surgical therapeutics hold the potential to improve the
patient’s overall health, by providing the control necessary to institute
lifestyle and nutritional improvements to maintain therapeutic effect, while
being easily removed once the desired effect has been attained and lifestyle
changes implemented.
“GI
Dynamics is pioneering a platform of non-surgical therapeutics that affect key
metabolic pathways resulting in gastric bypass-like resolution of type 2
diabetes and significant weight loss,” said Stuart A. Randle, chief executive
officer of GI Dynamics. “These data, published for the first time in Diabetes Technology and Therapeutics, further underscore the potential
role that EndoBarrier may play in the lives of people battling type 2 diabetes
and obesity, and the co-morbidities often associated with these challenging
chronic diseases.”
About the EndoBarrier™ Gastrointestinal Liner
The patented EndoBarrier Gastrointestinal
Liner is an advanced investigational, non-surgical medical device based on the
EndoBarrier Technology platform for treating type 2 diabetes and
obesity. The EndoBarrier Gastrointestinal Liner is placed in the GI tract
endoscopically (via the mouth) to create a barrier between food and the wall of
the intestine. Physicians believe that preventing food from coming into
contact with the intestinal wall may alter the activation of hormonal signals
that originate in the intestine, thus mimicking the effects of a Roux-en-Y
gastric bypass procedure without surgery. A growing body of preclinical
and clinical evidence supports the potential for EndoBarrier Gastrointestinal
Liner to dramatically change the treatment landscape for people living with type
2 diabetes, obese people at risk for type 2 diabetes, and people with severe
weight problems.
About GI Dynamics
GI Dynamics is focused on developing effective, non-surgical approaches for treating type 2 diabetes and obesity. The company’s patented EndoBarrier™ Technology has the potential to deliver medical interventions for people combating weight problems and diabetes or diabetes risk factors. Data from clinical trials demonstrate that the EndoBarrier™ Gastrointestinal Liner, an advanced device in the EndoBarrier portfolio, may provide rapid improvement in glycemic control and significant weight loss by modifying metabolic pathways.
The company is also developing the EndoBarrier Flow Restrictor, which is designed to further enhance the effectiveness of the liner by doubling the amount of weight-loss that can be achieved using the liner alone. Each device in the EndoBarrier portfolio is designed to assist patients gain control of their blood sugar and achieve a healthier body mass index (BMI). GI Dynamics is collaborating with experts in endocrinology, gastroenterology, bariatric surgery and medical weight loss on these efforts.
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