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STEP-1: EndoBarrier System Pivotal Trial(Rev E)

Sponsor
GI Dynamics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04101669
Collaborator
Biostatistical Consulting, Inc. (Other)
240
Enrollment
6
Locations
2
Arms
66.7
Anticipated Duration (Months)
40
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Device: EndoBarrier Liner
  • Other: Sham
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System. Patients will be randomized 3 (EndoBarrier):1 (Sham).A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the EndoBarrier System. Patients will be randomized 3 (EndoBarrier):1 (Sham).
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
The Investigators include interventional gastroenterologists (GI) and endocrinologists. The GI team: MD, PA and site coordinator, as well as radiology personnel will not be masked, while the endocrinologist team: the MDs, PAs, site coordinators and nutritionists, will be masked. The patient is also masked.
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 9, 2019
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: EndoBarrier

Patients in ARM 1, will receive an upper endoscopy and will be treated with the EndoBarrier Liner

Device: EndoBarrier Liner
The EndoBarrier System is provided as a single-use, sterile device and consists of an EndoBarrier Liner preloaded, packaged and sterilized within the EndoBarrier Delivery System. The EndoBarrier Delivery System is utilized to deliver the EndoBarrier Liner to the proximal small intestine. The EndoBarrier Liner is removed using the EndoBarrier Retrieval System. The EndoBarrier System incorporates no pharmacological, biological tissue or blood products.
Other Names:
  • EndoBarrier Sleeve
  • Duodenal-jejunal Bypass Liner (DJBL)

    		•
    Sham Comparator: Sham

    Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the EndoBarrier Liner.

    Other: Sham
    Patient receives upper endoscopy but no treatment

    Outcome Measures

    Primary Outcome Measures

    1. Change in HbA1c [One year]

      Change in HbA1c value from baseline to 12 months.

    Secondary Outcome Measures

    1. HbA1c value [1 and 2 years]

      Proportion of patients who achieve an HbA1c value of < 7 % by 12 months (52 weeks).

    2. Weight Loss [1 and 2 years]

      Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline

    3. Insulin use [1 and 2 years]

      Proportion of patients initiating insulin

    4. LDL cholesterol [1 and 2 years]

      Change in LDL cholesterol

    5. Triglycerides [1 and 2 years]

      Change in triglycerides

    6. Lower risk of CKD progression [1 and 2 years]

      Assessment of eGFR

    7. Lower risk of development of CKD [1 and 2 years]

      Assessment of eGFR

    8. Change in risk for kidney disease [1 and 2 years]

      Combined changes in eGFR and Albuminuria

    9. Blood pressure [1 and 2 years]

      Change in systolic blood pressure values

    10. Change in daily fasting glucose level [1 and 2 years]

      Change in fasting blood glucose values as measured by daily glucometer reading in mg/dL

    11. Change in Nonalcoholic Fatty Liver Disease (NAFLD) [1 and 2 years]

      Change in NAFLD, change in % liver fat using MRI (proton density fat fraction)

    12. Change in Nonalcoholic Steatohepatitis (NASH) [1 and 2 years]

      NASH- liver fibrosis % compared to baseline using using MRE measured in kPa

    13. Questionnaire [1 and 2 years]

      Change from baseline in treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    14. Questionnaire [1 and 2 years]

      Impact of weight on quality of life (IWQOL)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥30 years and ≤ 65 years

    2. Have understood and signed the approved informed consent form

    3. Diagnosis of type 2 diabetes for ≤ 15 years

    4. HbA1c ≥ 8.0% and ≤10%

    5. BMI ≥30kg/m2 and ≤ 50kg/m2

    6. Willing and able to comply with study requirements

    7. Documented negative pregnancy test in women of childbearing potential

    8. 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

    9. At least one year of medical records available, including detailed medical therapy and dosing information

    10. 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:

    1. Previous treatment with the EndoBarrier System

    2. 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

    3. 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)

    4. eGFR of less than 45 ml/min/1.73 m2

    5. Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage

    6. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement

    7. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis

    8. Fasting C-peptide < 1.0 ng/mL

    9. Triglyceride level > 600 mg/dL

    10. Vitamin D deficiency (<20ng/ml)

    11. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy

    12. Height < 5 feet (152.4 cm)

    13. 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

    14. History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)

    15. Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide

    16. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)

    17. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI.

    18. 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)

    19. 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

    20. 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

    1. Active H. pylori

    2. History of Crohn's disease, atresias or untreated stenoses

    3. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization

    4. 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

    5. Poor dentition not allowing complete chewing of food

    6. Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)

    7. Residing in a location without ready access to study site medical resources

    8. Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization

    9. Positive Fecal Immunochemical Test (FIT) at time of screening

    10. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan

    11. No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary

    12. 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

    13. Any condition that increases red cell turnover, such as thalassemia

    14. Existence of (>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K2

    15. A known sensitivity to nickel or titanium

    16. Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI conditional but not appropriate for the region of interest)

    17. Current use of insulin

    18. Patients with history or suspicion of coronary artery disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MedStar Health Research Institute Washington District of Columbia United States 20010
    2 University of Miami Hospital Miami Florida United States 33166
    3 Brigham and Women's Hospital Boston Massachusetts United States 02115
    4 Michigan Medicine, Division of Gastroenterology and Hepatology Ann Arbor Michigan United States 48109
    5 Jefferson University Hospital/Diabetes Research Center Philadelphia Pennsylvania United States 19107
    6 Baylor College of Medicine Houston Texas United States 77030

    Sponsors and Collaborators

    • GI Dynamics
    • Biostatistical Consulting, Inc.

    Investigators

    • Principal Investigator: Christopher C Thompson, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    GI Dynamics
    ClinicalTrials.gov Identifier:
    NCT04101669
    Other Study ID Numbers:
    • 18-1
    First Posted:
    Sep 24, 2019
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by GI Dynamics
    Type 2 Diabetes
    Obesity
    Additional relevant MeSH terms:
    Obesity
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Jun 14, 2022