Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Device: Duodenal Mucosal Resurfacing (DMR)Device: Duodenal Mucosal Resurfacing (Sham)
- Registration Number
- NCT04419779
- Lead Sponsor
- Fractyl Health Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Duodenal Mucosal Resurfacing (DMR) Duodenal Mucosal Resurfacing (DMR) 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. Duodenal Mucosal Resurfacing Sham (Sham) Duodenal Mucosal Resurfacing (Sham) 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.
- Primary Outcome Measures
Name Time Method Demonstrate superiority of Revita DMR to sham in improving glycemic control Baseline to Week 24 Change from baseline in HbA1c at Week 24
- Secondary Outcome Measures
Name Time Method Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks Baseline to Week 24 Percentage of total body weight loss (%TBWL) from baseline at Week 24
Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks Baseline to Week 24 The proportion of subjects who achieve an HbA1c of ≤7.0% at 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 4. The proportion of subjects who discontinued insulin at Week 24 in those subjects on insulin at baseline
Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks Baseline to Week 24 Change from baseline in fasting plasma glucose (FPG) at Week 24
Trial Locations
- Locations (58)
Helios CR, Inc
🇺🇸Phoenix, Arizona, United States
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Angel City Research , Inc.
🇺🇸Los Angeles, California, United States
UCLA Health
🇺🇸Los Angeles, California, United States
Care Access Santa Clarita
🇺🇸Newhall, California, United States
Hoag Hospital
🇺🇸Newport Beach, California, United States
Stanford University Medical Center
🇺🇸Redwood City, California, United States
Mills Peninsula Health Center
🇺🇸San Mateo, California, United States
Northeast Research Institute, Llc
🇺🇸Fleming Island, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Synexus Research
🇺🇸Orlando, Florida, United States
Northwestern Unviersity
🇺🇸Evanston, Illinois, United States
AHN - Avon
🇺🇸Avon, Indiana, United States
Investigators Research Group
🇺🇸Brownsburg, Indiana, United States
AHN- Franklin
🇺🇸Franklin, Indiana, United States
AHN - Greenfield
🇺🇸Greenfield, Indiana, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
AHN - Muncie
🇺🇸Muncie, Indiana, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Alcanza Clinical Research, LLC
🇺🇸Methuen, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
IMA Clinical Research St. Louis
🇺🇸Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Endocrine Associates of West Village
🇺🇸Long Island City, New York, United States
NYU Langone Gastroenterology Associates
🇺🇸New York, New York, United States
Synexus Clinical Research, New York
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
M3 Wake Research
🇺🇸Raleigh, North Carolina, United States
AcellaCare Salisbury
🇺🇸Salisbury, North Carolina, United States
AcellaCare Piedmont
🇺🇸Statesville, North Carolina, United States
AcellaCare Wilmington
🇺🇸Wilmington, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Preferred PCP - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Pittsburgh, Pennsylvania, United States
Care Access Warwick
🇺🇸Warwick, Rhode Island, United States
Baylor St. Luke's Medical Center
🇺🇸Houston, Texas, United States
Biopharma Informatic, Llc
🇺🇸Houston, Texas, United States
Simcare Medical Research, Llc.
🇺🇸Sugar Land, Texas, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Cliniques Universitaires de Bruxelles Hopital Erasme
🇧🇪Bruxelles, Belgium
University College Dublin
🇮🇪Dublin, Ireland
Italy Gemelli
🇮🇹Roma, Italy
Universiteit Van Amsterdam Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
University Hospital Zurich
🇨🇭Zürich, Switzerland
Cleveland Clinic London
🇬🇧London, England, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom