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Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese
Trial ID or NCT#
NCT01728116
Status
NOT RECRUITING
Purpose
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
Eligibility Criteria
Ages Eligible for Study: 21 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Tracey McLaughlin
Endocrinologist
Professor of Medicine (Endocrinology) at the Stanford University Medical Center
Marilyn Tan
Endocrinologist
Clinical Assistant Professor, Medicine - Endocrinology, Gerontology, & Metabolism
Contact us to find out if this trial is right for you.
CONTACT
Elizabeth Colbert
(650) 723-3186
View on ClinicalTrials.gov
About this Clinical Trial
Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese
Your Message Will Go To
Elizabeth Colbert650-723-3186