Meta-Analysis Show EndoBarrier Improves Glycemic Control, Induces Weight Loss in Patients with Type 2 Diabetes and Obesity
May 22 2017 - 7:26PM
Business Wire
- HbA1c: 1.3% mean reduction at
explant
- HbA1c: 1.0% mean reduction 6 months
post explant
- Total Body Weight: 14% mean reduction
at explant
GI Dynamics®, Inc. (ASX:GID), a medical device company that has
commercialized EndoBarrier® in Europe, the Middle East and South
America for patients with type 2 diabetes and obesity, today
announced data from an investigator-initiated meta-analysis of 14
studies showing EndoBarrier improves glycemic control in a
clinically impactful manner in patients with type 2 diabetes and
obesity. According to data presented at the Digestive Disease Week
(DDW) meeting in Chicago, EndoBarrier induces significant weight
loss and positively affects certain digestive hormones.
Pichamol Jirapinyo, M.D., Division of Gastroenterology,
Hepatology and Endoscopy at Brigham and Women’s Hospital and
Harvard Medical School in Boston, presented “The effect of the
duodenal-jejunal bypass liner on glycemic control in type-2
diabetic patients with obesity: a meta-analysis with secondary
analysis on weight loss and hormonal changes,” on 8 May at the
DDW meeting. Dr. Jirapinyo and the study team analyzed publicly
available data from 14 studies as part of the most comprehensive
meta-analysis of EndoBarrier to date.
HbA1c
HbA1c
change
# studies
#
patients
% HbA1c Reduction 1.3% 14 431 %
Reduction 15% % Reduction v Control
0.9% 4 123
6 months post
implant
% HbA1c Reduction
1.0% 2 99 Weight
Weight
Kg 12.6 10 395
TBWL 14% GH
Gut
Hormones
GIP (Hedges' g)
-0.36 5 84
Dr. Jirapinyo and the study team used a strict methodology to
determine inclusion and exclusion of the different potential
clinical studies. In addition, publication bias and potential bias
from large studies were accounted for. Authors were also contacted
for additional data.
“This meta-analysis is very encouraging as we continue to see
clinically significant reductions in HbA1c levels at 1.3% with 77%
retention of the eight-month implant duration of HbA1c and month 14
(six months’ post explant). Weight loss at the time of explant is
also clinically significant,” said Scott Schorer, president and CEO
of GI Dynamics “This analysis further reinforces the unique method
of treatment and highly differentiated clinical treatment effect of
EndoBarrier.”
Meta-analysis Highlights
Primary Outcomes:In 14 studies with a total
population of 431 patients, the average decrease of HbA1c was 1.3
percent at removal of EndoBarrier, following an average implant
duration of 8.4 months. Of note, in the earlier studies,
EndoBarrier was implanted for 6 months while later studies extended
this duration to 12 months. A subgroup analysis of four randomized
controlled trials (RCTs) with a patient population of 123, saw a
decrease in their HbA1c levels by 0.9% compared to the control
group.
Secondary Outcomes:Secondary outcomes in this meta-analysis
measured change in weight and digestive hormones at removal and
changes in HbA1c levels six months after EndoBarrier removal. Two
studies with six-month data after removal of EndoBarrier showed
HbA1c remained lower than baseline by 1.0%. As for weight loss, 10
studies with a total patient population of 395 patients reported
average weight loss of 14.2 % and average BMI reduction of 4.2
kg/m2.
In addition, in five studies with a population of 84 patients,
the meta-analysis showed a significant decrease in
glucose-dependent insulinotropic peptide (GIP) at 7.8 months.
Secondary outcomes also examined adverse events. The
meta-analysis revealed 16 serious adverse events with the most
common including abdominal pain, nausea and vomiting. No hepatic
abscesses were found in the published studies.
Study Design
This meta-analysis reviewed published,
randomized controlled trials and cohort studies found in MEDLINE,
EMBASE and Web of Science through 1 Nov 2016, that assessed
outcomes of EndoBarrier in patients with type 2 diabetes and
obesity. Data were pooled using a mixed-effect model or a
random-effect model for high heterogeneity. Of 593 potential
eligible studies, 18 were included and 7 studies provided
additional data.
About GI Dynamics
GI Dynamics, Inc. (ASX:GID), is the developer of EndoBarrier,
the first endoscopically-delivered device therapy approved for the
treatment of type 2 diabetes and obesity. EndoBarrier is not
approved for sale in the United States and is limited by federal
law to investigational use only in the United States. Founded in
2003, GI Dynamics is headquartered in Boston, Massachusetts. For
more information, please visit www.gidynamics.com.
Forward-Looking Statements
This announcement contains forward-looking statements concerning
our expectations regarding the effect of the CE mark suspension,
our ability to resolve nonconformance issues to the satisfaction of
our notified body, and the timing of any reinstatement of our CE
mark. These forward-looking statements are based on GI Dynamics
management’s current estimates and expectations of future events as
of the date of this announcement. Furthermore, the estimates are
subject to several risks and uncertainties that could cause actual
results to differ materially and adversely from those indicated in
or implied by such forward-looking statements. These risks and
uncertainties include but are not limited to, risks associated with
obtaining funding from third parties; the consequences of stopping
the ENDO trial and the possibility that future clinical trials will
not be successful or confirm earlier results; the timing and costs
of clinical trials; the timing of regulatory submissions; the
timing, receipt and maintenance of regulatory approvals; the timing
and amount of other expenses; the timing and extent of third-party
reimbursement; risks associated with commercial product sales,
including product performance, competition, market acceptance of
products, intellectual-property risk; risks related to excess
inventory; and risks related to assumptions regarding the size of
the available market, the benefits of our products, product
pricing, timing of product launches, future financial results and
other factors, including those described in our filings with the
U.S. Securities and Exchange Commission. Given these uncertainties,
one should not place undue reliance on these forward-looking
statements. We do not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information or future events or otherwise, unless we are required
to do so by law.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170522006457/en/
GI Dynamics, Inc.Investor RelationsUnited States:Janell
Shields, +1-781-357-3280Investor
Relationsinvestor@gidynamics.comorMedia RelationsUnited
States:Nicole Franklin, +1-617-657-1312nfranklin@jpa.com
Gi Dynamics (ASX:GID)
Historical Stock Chart
From Mar 2024 to Apr 2024
Gi Dynamics (ASX:GID)
Historical Stock Chart
From Apr 2023 to Apr 2024