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

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 either the device or sham treatment group if they qualify for the study. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.

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