Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese



Status:Terminated
Conditions:Obesity Weight Loss, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - 65
Updated:4/21/2016
Start Date:December 2012
End Date:December 2016

Use our guide to learn which trials are right for you!

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents

To determine if the EndoBarrier safely and effectively improves glycemic control in obese
subjects with type 2 diabetes

This is a randomized, double blinded, prospective study. Subjects will be evaluated and
randomized to a treatment group if they qualify for the study. Subjects will receive either
a device or sham procedure. Throughout the study glycemic control and various laboratory
tests will be evaluated. A comparison of glycemic control between the two groups will be
assessed as the primary outcome measurement.

Inclusion Criteria:

- HbA1c ≥ 7.5% and ≤ 10%

- BMI ≥ 30 and ≤ 55

Exclusion Criteria:

- Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis

- C-peptide < 1.0 ng/mL

- Previous GI surgery or abnormal GI anatomical finding

- Prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent)
We found this trial at
25
sites
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
?
mi
from
New York, NY
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
?
mi
from
Billings, MT
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hyattsville, Maryland 20782
?
mi
from
Hyattsville, MD
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Louisville, Kentucky 40217
?
mi
from
Louisville, KY
Click here to add this to my saved trials
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Portland, Oregon 97232
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
St Louis, Missouri 63110
?
mi
from
St Louis, MO
Click here to add this to my saved trials