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

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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)
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
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201 Dowman Dr
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1720 2nd Ave S
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185 Cambridge Street
Boston, Massachusetts 02114
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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305 1st Avenue # Dazian 7
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291 Campus Dr
Stanford, California 94305
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500 S State St
Ann Arbor, Michigan 48109
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801 North 29th Street
Billings, Montana 59107
406-238-2500
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Boston, Massachusetts 02118
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Chapel Hill, North Carolina 27599
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303 East Superior Street
Chicago, Illinois 60611
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Dallas, Texas 75230
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2201 Inwood Rd
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Louisville, Kentucky 40217
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
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Portland, Oregon 97232
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