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

Not Recruiting

Trial ID: NCT01728116


To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

Official Title

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

Stanford Investigator(s)

Marilyn Tan
Marilyn Tan

Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism


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

   - 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,

   - 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

   - Positive stool guaiac at time of screening


device: EndoBarrier

procedure: Sham Procedure

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Colbert