Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

Inclusion Criteria:

• Subjects Age > 18 years and ≤65 years - Male or Female
• Subjects with Type 2 Diabetes > 1 and ≤ 10 years in duration
• Subjects with an Hb A1c level > 7.5 and ≤ 10.0
• Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required.
• Subjects with a BMI > 30 and< 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 contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.

Exclusion Criteria:

• Subjects taking DPP4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide)

• Subjects requiring insulin >150 units per day

  • Subjects with probable insulin production failure (fasting C Peptide serum <1.0 ng/mL)

• Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
• Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period
• 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 study participation
• Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
• Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.)
• 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 severe liver or kidney failure (serum creatinine >180mmol/l)
• Subjects with poor dentition who can not adequately chew their food