Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

NCT02879383 | Completed Results DMC

• 1 other identifier: C-30000
• Study Type: interventional
• Target: 109
• Locations: 5 countries
• Sites: 11

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal mucosal resurfacing (DMR) Procedure using the Revita System compared to a sham procedure for the treatment of uncontrolled type 2 diabetes. Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham treatment arm will cross over to receive the DMR treatment at 24 weeks with background medications held constant from 24-48 weeks of follow up.

Conditions

Diabetes Mellitus, Type 2; Noninsulin-Dependent Diabetes Mellitus

Keywords

Type 2 Diabetes, Revita System, DMR

Outcome Measures

Primary Outcomes (2)

• Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham.

  The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham

  Baseline and 24 Weeks post-procedure

• Change From Baseline at 12 Weeks in MR-PDFF, DMR vs Sham

  The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF \> 5% , DMR vs Sham

  Baseline and 12 Weeks post-procedure

Study Arms (2)

DMR Procedure

EXPERIMENTAL

Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.

Procedure: DMR Procedure

Sham Procedure

SHAM COMPARATOR

Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.

Procedure: Sham Procedure

Interventions

DMR Procedure PROCEDURE

The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System

Also known as: DMR, Revita

DMR Procedure

Sham Procedure PROCEDURE

The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.

Sham Procedure

Eligibility Criteria

• Age: 28 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Diagnosed with Type 2 Diabetes and evidence of preserved insulin secretion. Fasting insulin \> 7 μU/ mL.
• Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol)
• Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
• Currently taking one or more oral glucose lowering medications of which one must be Metformin, with no changes in dose or medication in the previous 12 Weeks prior to study entry
• Able to comply with study requirements and understand and sign the informed consent

You may not qualify if:

• Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
• Current use of Insulin
• Current use of Glucagon-like peptide-1 (GLP-1) analogues
• Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
• Known autoimmune disease, as evidenced by a positive Anti- Glutamic Acid Decarboxylase (GAD) test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.)
• Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
• History of chronic or acute pancreatitis
• Known active hepatitis or active liver disease
• Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
• History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
• Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
• Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
• Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
• Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)

Sponsors & Collaborators

• Fractyl Health Inc.: lead

Study Sites (11)

Hopital Erasme

Brussels, 1070, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

ABC Hospital

São Paulo, Brazil

Location

Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo

São Paulo, Brazil

Location

Policlinico Gemelli (Sacro Cuore)

Rome, Lazio, Italy

Location

Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano

Milan, 20089, Italy

Location

Amsterdam University Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

University College London Hospitals

London, NW1 2BU, United Kingdom

Location

King's College, Denmark Hill

London, United Kingdom

Location

Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Mingrone G, van Baar AC, Deviere J, Hopkins D, Moura E, Cercato C, Rajagopalan H, Lopez-Talavera JC, White K, Bhambhani V, Costamagna G, Haidry R, Grecco E, Galvao Neto M, Aithal G, Repici A, Hayee B, Haji A, Morris AJ, Bisschops R, Chouhan MD, Sakai NS, Bhatt DL, Sanyal AJ, Bergman JJGHM; Investigators of the REVITA-2 Study. Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial. Gut. 2022 Feb;71(2):254-264. doi: 10.1136/gutjnl-2020-323608. Epub 2021 Feb 17.

  PMID: 33597157 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR N=39; sham N=37) and Brazilian (DMR N=17; sham N=16) populations, therefore, results were stratified by region. Limitations of this feasibility study include the relatively small patient population and heterogeneity between European and Brazilian populations.

Results Point of Contact

• Title: Sarah Hackett, Director of Clinical Operations
• Organization: Fractyl Laboratories, Inc.

shackett@fractyl.com

(781) 902-8840

Study Officials

• Geltrude Mingrone, MD, PhD

  Gemelli University Hospital, Rome

  PRINCIPAL INVESTIGATOR

• Jacques Bergman, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 25, 2016
• Study Start: March 1, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 14, 2024
• Results First Posted: May 25, 2021

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); GB (4); BR (2); NL (1); IT (2)