RESET System Pivotal Trial (Rev F) (STEP-1)

July 16, 2024 updated by: Morphic Medical Inc.

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET® System for Glycemic Improvement in Patients With Inadequately Controlled Type 2 Diabetes and Obesity

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET 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 RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 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 (RESET):1 (Sham).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the safety and effectiveness of the RESET System when used with moderate intensity lifestyle and dietary counseling and medical management, in patients with baseline HbA1c ≥ 7.5% and ≤10%, and BMI ≥ 30 kg/m2 and ≤ 50kg/m2, whose diabetes medications consist of at least dual therapy for 3 months, yet have not achieved adequate HbA1c control (<7%).

Specific objectives of this study are:

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

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Health Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Brebbia, MD
        • Sub-Investigator:
          • Jean Park, MD
        • Sub-Investigator:
          • Adline Ghazi, MD
        • Sub-Investigator:
          • Nasrin Ansari, MD
    • Florida
      • Miami, Florida, United States, 33166
        • Recruiting
        • University of Miami Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nestor De La Cruz, MD
        • Sub-Investigator:
          • Gianluca Iacobellis, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Christopher C Thompson, MD
        • Sub-Investigator:
          • Pichamol Jirapinyo, MD
        • Sub-Investigator:
          • Marvin Ryou, MD
        • Sub-Investigator:
          • Caroline Apovian, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Michigan Medicine, Division of Gastroenterology and Hepatology
        • Contact:
        • Principal Investigator:
          • Allison R Schulman, MD
        • Sub-Investigator:
          • Elif A Oral, MD
        • Sub-Investigator:
          • Richard s Kwon, MD
        • Sub-Investigator:
          • Andrew T Krafton, MD
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reem Sharaiha, MD
        • Sub-Investigator:
          • David Carr-Locke, MD
        • Sub-Investigator:
          • Shrihari Mahadev, MD
        • Sub-Investigator:
          • Kartik Sampath, MD
        • Sub-Investigator:
          • Andrea Herr, MD
        • Sub-Investigator:
          • Louis Aronne, MD
        • Sub-Investigator:
          • Alpana Shukla, MD
        • Sub-Investigator:
          • Beverly Tchang, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto Simons-Linares, MD
        • Sub-Investigator:
          • Marcio Griebeler, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wasif M Abidi, MD
        • Sub-Investigator:
          • Kalpesh Patel, MD
        • Sub-Investigator:
          • Mandeep Bajaj, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥22 years and ≤ 65 years
  2. Have understood and signed the approved informed consent form
  3. Diagnosis of type 2 diabetes
  4. HbA1c ≥ 7.5% 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 1 form 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 (<7.5%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin, SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.

Exclusion Criteria:

  1. Previous treatment with the RESET System
  2. Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner
  3. Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance
  4. 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)
  5. eGFR of less than 45 ml/min/1.73 m2
  6. Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
  7. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
  8. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
  9. Fasting C-peptide < 1.0 ng/mL
  10. Triglyceride level > 600 mg/dL
  11. Vitamin D deficiency (<20ng/ml)
  12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
  13. Height < 5 feet (152.4 cm)
  14. Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
  15. History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)
  16. Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide
  17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
  18. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI.
  19. 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)
  20. 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 9 months post implant procedure

  21. 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

  22. Active H. pylori
  23. History of Crohn's disease, atresias or untreated stenoses
  24. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization
  25. Patients may be disqualified for study inclusion for any condition determined by the PI that places the patient at undue risk
  26. Poor dentition not allowing complete chewing of food
  27. Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)
  28. Residing in a location without ready access to study site medical resources
  29. Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
  30. Positive Fecal Immunochemical Test (FIT) at time of screening
  31. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan
  32. No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary
  33. 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
  34. Any condition that increases red cell turnover, such as thalassemia
  35. Existence of (>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K2
  36. A known sensitivity to nickel or titanium
  37. Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI conditional but not appropriate for the region of interest)
  38. Patients with history or suspicion of coronary artery disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RESET
Patients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner
Device: RESET Liner
The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.
Other Names:
  • Duodenal-jejunal Bypass Liner (DJBL)
  • EndoBarrier
  • RESET Sleeve
Sham Comparator: Sham
Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner.
Other: Sham
Patient receives upper endoscopy but no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 9 Months
Change in HbA1c value from baseline to 9 months.
9 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c value
Time Frame: 9 and 21 months
Proportion of patients who achieve an HbA1c value of < 7 %
9 and 21 months
Weight Loss
Time Frame: 9 and 21 months
Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline
9 and 21 months
Insulin use
Time Frame: 9 and 21 months
Proportion of patients reducing insulin dosage
9 and 21 months
LDL cholesterol
Time Frame: 9 and 21 months
Chnage in LDL cholesterol
9 and 21 months
Triglycerides
Time Frame: 9 and 21 months
Change in triglycerides
9 and 21 months
Blood pressure
Time Frame: 9 and 21 months
Change in systolic blood pressure values
9 and 21 months
Fasting blood glucose level
Time Frame: 9 and 21 months
Change in fasting blood glucose values
9 and 21 months
Vitamin D
Time Frame: 9 and 21 months
Change in vitamin D levels
9 and 21 months
Vitamin D Supplementation
Time Frame: 9 and 21 months
Average vitamin D levels required to maintain normal vitamin D levels
9 and 21 months
Refractory to Vitamin D Supplementation
Time Frame: 9 and 21 months
Proportion of patients refractory to vitamin D supplementation
9 and 21 months
Serum Creatinine
Time Frame: 9 and 21 months
Change in serum creatinine levels
9 and 21 months
eGFR
Time Frame: 9 and 21 months
Change in eGFR levels
9 and 21 months
Change in Nonalcoholic Fatty Liver Disease (NAFLD)
Time Frame: 9 and 21 months
Change in NAFLD, change in % liver fat using MRI (proton density fat fraction)
9 and 21 months
Change in Nonalcoholic Steatohepatitis (NASH)
Time Frame: 9 and 21 months
NASH- liver fibrosis % compared to baseline using using MRE measured in kPa
9 and 21 months
DTSQ Questionnaire
Time Frame: 9 and 21 months
Change from baseline in treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ)
9 and 21 months
IWQOL Questionnaire
Time Frame: 9 and 21 months
Impact of weight on quality of life (IWQOL)
9 and 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morphic Medical Inc.

Collaborators

Biostatistical Consulting, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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