Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes

The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.

Inclusion Criteria:

• Subjects Age > 18 years and ≤ 55 years
• Male or Female
• Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
• Subjects with an HbA1C > 7.5 and ≤ 10.0%
• Subjects with a BMI > 26 - < 50
• Subjects willing to comply with study requirements
• Subjects who have signed an informed consent form
• Women who are post-menopausal, surgically sterile or on oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial.

Exclusion Criteria:

• Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
• Subjects requiring insulin
• Subjects with probable insulin production failure (fasting C Peptide serum <1ng/mL)
• Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
• Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening
• Subjects requiring prescription anticoagulation therapy
• Subjects with or a history of iron deficiency and/or iron deficiency anemia
• Subjects with or a history of abnormalities of the GI tract
• Subjects with symptomatic gallstones or kidney stones at the time of screening
• Subjects with a known infection
• Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
• Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the Subject a poor candidate for device placement or clinical trial participation
• Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
• Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
• Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
• Subjects receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
• Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Subjects with active and uncontrolled GERD
• Subjects with a known history of substance abuse
• Subjects participating in another ongoing investigational clinical trial
• Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)