EndoBarrier System Pivotal Trial(Rev B)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    240
  • sponsor
    GI Dynamics
Updated on 12 February 2021

Summary

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study.

A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System plus moderate intensity lifestyle and dietary counseling compliant with 2019 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (EndoBarrier):1 (Sham).

Description

The objective of this study is to evaluate the safety and effectiveness of the EndoBarrier System when used with moderate intensity lifestyle and dietary counseling and medical management, in patients with baseline HbA1c 8.0% and 10%, and BMI 30 kg/m2 and 50kg/m2, whose diabetes medications consist of at least dual therapy for 3 months, excluding insulin, yet have not achieved adequate HbA1c control (<7%).

Specific objectives of this study are:

  1. To determine if the EndoBarrier System significantly improves glycemic control
  2. To determine that the EndoBarrier System can be safely used to improve glycemic control

Details
Condition adiposity, Obesity, Diabetes type2
Treatment SHAM, EndoBarrier Liner
Clinical Study IdentifierNCT04101669
SponsorGI Dynamics
Last Modified on12 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 30 yrs and 55 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes type2 or Obesity or adiposity?
Age 30 years and 65 years
Have understood and signed the approved informed consent form
Diagnosis of type 2 diabetes for 15 years
HbA1c 8.0% and 10%
BMI 30kg/m2 and 50kg/m2
Willing and able to comply with study requirements
Documented negative pregnancy test in women of childbearing potential
Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 2 forms of birth-control to prevent unwanted pregnancies
At least one year of medical records available, including detailed medical therapy and dosing information
Failed to achieve adequate HbA1c reduction (<8%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including metformin, SGLT-2 inhibitor, GLP-1 RA or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s. Use of insulin is an exclusion criterion. Patients should be at 70% of maximum dosage of diabetes medications or highest tolerable dosage

Exclusion Criteria

Previous treatment with the EndoBarrier System
Previous GI surgery that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner, or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner
Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)
eGFR of less than 45 ml/min/1.73 m2
Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
Fasting C-peptide < 1.0 ng/mL
Triglyceride level > 600 mg/dL
Vitamin D deficiency (<30ng/ml)
Male patients with serum creatinine (Cr) >1.5 mg/dl or female patients with Cr >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 or past alcohol addiction, current or past drug addiction, or current drug usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)
Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI
Uncontrolled thyroid disease, including a history of thyroid cancer, hyperthyroidism, or taking thyroid hormone for any reason other than primary hypothyroidism (TSH level must be between 0.4-4)
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 implant procedure
Currently taking the following medications (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
Restricted Medications/Supplements Systemic corticosteroids Proton Pump
Inhibitor (PPI) Drugs known to affect GI motility (e.g.metoclopramide)
Prescription or over-the-counter weight loss medication(s) Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and other anti-inflammatory
medication for study duration Medications known to cause significant weight
gain or weight loss (e.g. chemotherapeutics)
Supplements that are known or suspected to increase bleeding risk including
but not limited to
Gingko biloba Ginseng Vitamins C & E Turmeric St. John's wort Evening primrose
oil Feverfew Green Tea Extract
\. Allergy or hypersensitivity to cephalosporins or penicillin and all
equivalent antibiotics
\. Active H. pylori
\. History of Crohn's disease, atresias or untreated stenoses
\. Abnormal pathologies or conditions of the gastrointestinal tract
including ulcers or upper gastrointestinal bleeding conditions within 3 months
of randomization
\. Any condition or major illness that places the patient at undue risk by
participating in the study, including but not limited to, patients at
significant risk for surgery because of potential need for surgery to address
adverse events
\. 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 5% total body weight (TBW) anytime during the 3
months preceding randomization
\. Positive Fecal Immunochemical Test (FIT) at time of screening
\. History or observation of psychological disorder or behavior which could
preclude compliance to the treatment and follow up plan
\. No access to an active telephone and internet service for provision of
Follow Up Schedule calls and electronic diary
\. Having donated blood or received a blood transfusion in the 90 days prior
to baseline labs. Patients should agree not to donate blood during the study
\. Any condition that increases red cell turnover, such as thalassemia
\. Existence of (>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas
maltophilia and/or Klebsiella pneumoniae serotype K1 and K2
\. A known sensitivity to nickel or titanium
\. Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI
conditional but not appropriate for the region of interest)
\. Current use of insulin
\. Patients with history or suspicion of coronary artery disease
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