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

GI Dynamics

Status

Terminated

Conditions

Obesity

Type 2 Diabetes

Treatments

Device: EndoBarrier

Procedure: Sham Procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT01728116

09-1

Details and patient eligibility

About

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

Full description

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.

Enrollment

325 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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