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

Inclusion Criteria: * Males/females aged ≥ 21 years and ≤ 65 years * Diagnosis of Type 2 Diabetes for ≤ 20 years * Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2) * Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i or TZD) * Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%. * Subjects willing to comply with study requirements * Subjects who have signed an informed consent form Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis * C-peptide \< 1.0 ng/mL * Triglyceride level \> 400 mg/dL * Vitamin D deficiency (\<20 ng/mL) * Male subjects with serum Creatinine \>1.5 mg/dl or female subjects with Creatinine \>1.4 mg/dL * Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy * Height \< 5 feet (152.4 cm) * Current alcohol or drug addiction * Symptomatic kidney stones or gallstones within 6 months prior to randomization * Chronic pancreatitis or acute pancreatitis within 12 months of randomization * Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide * Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma) * Active gastroesophageal reflux disease \[GERD\] uncontrolled with a Proton Pump Inhibitor (PPI) * Thyroid disease unless controlled with medication * Currently taking Non-Steroidal Anti-Inflammatory Drugs \[NSAIDs\] (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected use of these agents during the trial 12 months post index procedure * Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post index procedure * Currently taking systemic corticosteroids, drugs known to affect GI motility, prescription/over-the-counter weight loss medications, or medications known to cause significant weight gain or weight loss within 30 days prior to randomization and/or there is a need or expected need to use these medications during the trial 12 months post index procedure * Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or insulin) within 3 months of screening * Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers * Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any equivalent antibiotics * Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening) * Previous GI surgery or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier device, liner or affect the function of the liner * Abnormal pathologies or conditions of the gastrointestinal tract, including current ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper gastrointestinal bleeding conditions within 3 months of randomization * Any condition or major illness that places the subject at undue risk by participating in the study * Poor dentition not allowing complete chewing of food * Enrolled in another investigational study within 3 months of screening for this study (Enrollment in observational studies is permitted) * Residing in a location without ready access to study site medical resources * Documented weight loss of \>10 pounds anytime during the 3 months preceding randomization * Positive stool guaiac at time of screening