EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects

Inclusion Criteria:

• Age > 21 years and < 65 years - male or female
• Overweight or obese individuals (BMI ≥ 27 kg/m2 and ≤ 40 kg/m2)
• Diagnosed with Type 2 diabetes and being treated by diet or oral agents (metformin, SU, DPP-4i, or TZD)
• Glycemic state: HbA1c at screening 7.0-10.0%.
• History of failure with non-surgical weight loss methods
• Subjects willing to comply with study requirements
• Subjects who have signed an informed consent form

Exclusion Criteria:

Diabetic subjects requiring injectable treatments (insulin, GLP-1R agonists)

• Subjects requiring anticoagulation therapy
• Subjects with iron deficiency and iron deficiency anemia
• Condition of the gastrointestinal tract, such as ulcers or inflammatory bowel disease
• Treatment represents an unreasonable risk to the subject
• Known history of acute or chronic pancreatitis
• Known history of organ failure (i.e. renal insufficiency, heart failure, fibrotic / cirrhotic liver disease, or pulmonary disease)
• Symptomatic coronary artery disease or pulmonary dysfunction
• Subjects with known symptomatic biliary disease
• Known infection at the time of implant
• Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
• Congenital or acquired anomalies of the GI tract such as atresias or stenoses
• Pregnant or has the intention of becoming pregnant in the next 6 months
• Unresolved alcohol or drug addiction
• HIV positive subjects
• Subjects with hepatitis B or C
• Currently taking the following medications within 30 days of implant:

systemic corticosteroids, drugs known to affect GI motility, prescription or over the counter weight loss medications such as Sibutramine hydrochloride monohydrate and Orlistat

• Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
• Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement in this clinical trial
• Previous GI surgery that could affect the ability to place the liner or the function of the implant.
• Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
• H. pylori positive subjects (Note: patients may be enrolled if they had a prior history and were successfully treated).
• Family or subject history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Unable to tolerate proton pump inhibitors
• Participating in another ongoing investigational clinical trial that is ongoing or within 3 months of the implant date
• Positive stool guaiac at time of screening