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

Trial ID or NCT#

NCT01728116

Status

not recruiting iconNOT 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:
  1. * 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:
  1. * 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
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Investigator(s)

Marilyn Tan
Marilyn Tan
Endocrinologist
Clinical Associate 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