Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes

NCT04419779 | Suspended DMC FDA Device

• 1 other identifier: C-00044
• Study Type: interventional
• Target: 320
• Locations: 7 countries
• Sites: 58

Brief Summary

The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Revita System; Duodenal Mucosal Resurfacing; Insulin-Dependent Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Demonstrate superiority of Revita DMR to sham in improving glycemic control

  Change from baseline in HbA1c at Week 24

  Baseline to Week 24

Secondary Outcomes (4)

• Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks

  Baseline to Week 24

• Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks

  Baseline to Week 24

• Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks

  Baseline to Week 24

• To demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks in those subjects on insulin at baseline

  Baseline to Week 24

Study Arms (2)

Duodenal Mucosal Resurfacing (DMR)

ACTIVE COMPARATOR

Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with inadequately controlled type 2 diabetes.

Device: Duodenal Mucosal Resurfacing (DMR)

Duodenal Mucosal Resurfacing Sham (Sham)

SHAM COMPARATOR

Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with inadequately controlled type 2 diabetes.

Device: Duodenal Mucosal Resurfacing (Sham)

Interventions

Duodenal Mucosal Resurfacing (DMR) DEVICE

The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.

Duodenal Mucosal Resurfacing (DMR)

Duodenal Mucosal Resurfacing (Sham) DEVICE

The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.

Duodenal Mucosal Resurfacing Sham (Sham)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant non-lactating females
• Age between 21 and 70 years (both inclusive)
• Subjects on at least one glucose lowering agent (GLA) with no changes in GLA medications or dosing for at least 12 weeks prior to the screening visit
• Permitted GLAs include:
• Metformin,
• GLP-1 RA including dual peptide agonists and related molecules (e.g., GLP-1/GIP RA),
• DPP-4i,
• TZDs,
• SGLT2is,
• SUs,
• Meglitinides,
• Insulin (basal or basal combined with short-acting), up to a total of 100 units daily
• HbA1c of 7.5%-10% (both inclusive)
• BMI \>24 to ≤40 kg/m2
• WOCBP should have a negative urine beta hCG pregnancy test and must agree to use two of the established contraceptive methods throughout the study duration

You may not qualify if:

• FPG ≥270 mg/dL
• Known case of absolute insulin deficiency as indicated by clinical assessment or a fasting plasma C-peptide of \<0.6 ng/mL
• Recurrent or severe urinary tract or genital mycotic infections or history of GU infection within 4 weeks prior to informed consent, for those subjects on SGLT-2
• ALT or AST \>3 times upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.
• Use of an investigational drug within 1 month or 5 half-lives (whichever is longer) before screening
• Diagnosed with type 1 diabetes or with a recent history of DKA within one year prior to screening
• Ketosis-prone T2D
• Known diabetes related non-healing ulcers or amputations (with the exception of a finger or toe amputation occurring \> 1 year prior to screening.
• History of more than 1 severe hypoglycemia episode or hypoglycemia unawareness within the last 6 months
• Clinically significant hypoglycemia occurring during the run-in period, defined as a) 2 or more glucose alert values of ≤70 mg/dL (3.9 mmol/L) unless a clear, correctable, precipitating factor can be identified; b) clinically significant hypoglycemia with self-monitored or laboratory plasma glucose level \<54 mg/dL (3.0 mmol/L); or c) severe hypoglycemic episode requiring third party assistance
• Known intestinal autoimmune disease including celiac disease, ulcerative colitis, Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder that affects the small intestine
• Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid stimulating hormone \[TSH\] value outside the normal range at screening as determined by the central laboratory).
• Known thyroid cancer or hyperthyroidism with treatment within the past 12 months or inadequately controlled hyperthyroidism (TSH value outside the normal range at screening as determined by the central laboratory).
• An uncontrolled endocrine condition such as multiple endocrine neoplasia (except T2D)
• Known structural or functional disorder of the esophagus including any swallowing disorder, esophageal chest pain disorders, drug-refractory esophageal reflux symptoms, or active and uncontrolled gastroesophageal reflux disease (GERD) (defined as Los Angeles Grade C or D esophagitis)

Sponsors & Collaborators

• Fractyl Health Inc.: lead

Study Sites (58)

Helios CR, Inc

Phoenix, Arizona, 85028, United States

Location

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Angel City Research , Inc.

Los Angeles, California, 90010, United States

Location

UCLA Health

Los Angeles, California, 90095, United States

Location

Care Access Santa Clarita

Newhall, California, 91321, United States

Location

Hoag Hospital

Newport Beach, California, 92663, United States

Location

Stanford University Medical Center

Redwood City, California, 94063, United States

Location

Mills Peninsula Health Center

San Mateo, California, 94401, United States

Location

Northeast Research Institute, Llc

Fleming Island, Florida, 32003, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

West Orange Endocrinology

Ocoee, Florida, 34761, United States

Location

Advent Health Orlando

Orlando, Florida, 32804, United States

Location

Synexus Research

Orlando, Florida, 32806, United States

Location

Northwestern Unviersity

Evanston, Illinois, 60611, United States

Location

AHN - Avon

Avon, Indiana, 46123, United States

Location

Investigators Research Group

Brownsburg, Indiana, 46112, United States

Location

AHN- Franklin

Franklin, Indiana, 46131, United States

Location

AHN - Greenfield

Greenfield, Indiana, 46140, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

AHN - Muncie

Muncie, Indiana, 47304, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Alcanza Clinical Research, LLC

Methuen, Massachusetts, 01844, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Jefferson City Medical Group

Jefferson City, Missouri, 65109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

IMA Clinical Research St. Louis

St Louis, Missouri, 63117, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Endocrine Associates of West Village

Long Island City, New York, 77089, United States

Location

NYU Langone Gastroenterology Associates

New York, New York, 10016, United States

Location

Synexus Clinical Research, New York

New York, New York, 10017, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

M3 Wake Research

Raleigh, North Carolina, 27612, United States

Location

AcellaCare Salisbury

Salisbury, North Carolina, 28144, United States

Location

AcellaCare Piedmont

Statesville, North Carolina, 28625, United States

Location

AcellaCare Wilmington

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Preferred PCP - Pittsburgh

Pittsburgh, Pennsylvania, 15201, United States

Location

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, 15236, United States

Location

Care Access Warwick

Warwick, Rhode Island, 02886-4463, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Biopharma Informatic, Llc

Houston, Texas, 77089, United States

Location

Simcare Medical Research, Llc.

Sugar Land, Texas, 77478, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98104, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, Belgium

Location

University College Dublin

Dublin, Ireland

Location

Italy Gemelli

Roma, Italy

Location

Universiteit Van Amsterdam Academisch Medisch Centrum

Amsterdam, Netherlands

Location

University Hospital Zurich

Zurich, CH-8091, Switzerland

Location

Cleveland Clinic London

London, England, SW1X &AW, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: March 8, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); US (51); IE (1); NL (1); BE (1); CH (1); GB (2)