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

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ClinicalTrials.gov Identifier: NCT02879383
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Fractyl Laboratories, Inc.

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Noninsulin-Dependent Diabetes Mellitus Procedure: DMR Procedure Procedure: Sham Procedure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DMR Procedure
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
Procedure: DMR Procedure
The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Other Names:
  • DMR
  • Revita

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




Primary Outcome Measures :
  1. Change from baseline at 24 weeks in hemoglobin A1c (HbA1c), DMR vs Sham. [ Time Frame: 24 Weeks post-procedure ]
    The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham



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Ages Eligible for Study:   28 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 28-75 years of age
  2. Diagnosed with Type 2 Diabetes and evidence of preserved insulin secretion. Fasting insulin > 7 μU/ mL.
  3. Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol)
  4. Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
  5. 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
  6. Able to comply with study requirements and understand and sign the informed consent

Exclusion Criteria:

  1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
  2. Current use of Insulin
  3. Current use of Glucagon-like peptide-1 (GLP-1) analogues
  4. 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)
  5. 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
  6. 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.)
  7. 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
  8. History of chronic or acute pancreatitis
  9. Known active hepatitis or active liver disease
  10. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
  11. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
  12. Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
  13. 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.
  14. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
  15. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
  16. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
  17. Persistent Anemia, defined as Hgb<10 g/dl
  18. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Diseae (MDRD) <30 ml/min/1.73m^2
  19. Active systemic infection
  20. Active malignancy within the last 5 years
  21. Not potential candidates for surgery or general anesthesia
  22. Active illicit substance abuse or alcoholism
  23. Participating in another ongoing clinical trial of an investigational drug or device
  24. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879383


Contacts
Contact: Karen Hager 781-902-8840 Khager@fractyl.com
Contact: Jay Caplan 781-325-8811 Jay@fractyl.com

Locations
Belgium
Hopital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Aicha Hamouda    +32 2 555 72 91    Aicha.Hamouda@erasme.ulb.ac.be   
Contact: Mona Hammam    +32 (0) 2 555 47 64    mona.hammam@erasme.ulb.ac.be   
Principal Investigator: Jacques Deviere, MD, Prof.         
Sub-Investigator: Laurent Crenier, MD         
UZ Leuven Recruiting
Leuven, Belgium
Contact: Sophie Achten       sophie.achten@uzleuven.be   
Principal Investigator: Raf Bisschops, MD         
Sub-Investigator: Ann Mertens, MD         
Brazil
Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo Recruiting
Sao Paulo, Brazil
Contact: Ana Carolina Candido    +55 11 94131-4975    ana.candido@hc.fm.usp.br   
Principal Investigator: Eduardo G Hourneaux de Moura, MD         
ABC Hospital Recruiting
São Paulo, Brazil
Contact: Bruno Rosa       bruno.rosa@fmabc.br   
Principal Investigator: Eduardo Grecco         
Sub-Investigator: Ana Teresa Santomauro         
Italy
Policlinico Gemelli (Sacro Cuore) Recruiting
Rome, Lazio, Italy
Contact: Carolina Gualtieri       carolina.gualtieri@policlinicogemelli.it   
Principal Investigator: Geltrude Mingrone, MD         
Sub-Investigator: Guido Costamagna, MD         
Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano Recruiting
Milano, Italy, 20089
Contact: Elena Finati       elena.finati@cancercenter.humanitas.it   
Principal Investigator: Alessandro Repici, MD         
Sub-Investigator: Andrea Lania         
United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom, G4 0SF
Contact: Hilary Peddie       hilary.peddie@ggc.scot.nhs.uk   
Principal Investigator: John Morris, MB FRCP         
Sub-Investigator: Russell Drummond, BSc, MBCHB, MD, FRCP         
University College London Hospitals Recruiting
London, United Kingdom, NW1 2BU
Contact: Cormac McGee, MD    07572 130 166    RevitaTrial@uclh.nhs.uk   
Principal Investigator: Rehan Haidry, MD         
Sub-Investigator: Rachel Batterham, MD         
King's College, Denmark Hill Recruiting
London, United Kingdom
Contact: Marcia Henderson-Wilson       Marcia.Henderson-Wilson@kcl.ac.uk   
Principal Investigator: David Hopkins, MD         
Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Gayna Babington       Gayna.Babington@nuh.nhs.uk   
Principal Investigator: Krish Ragunath, MD FRCP FASGE         
Sub-Investigator: Idris Iskander         
Sponsors and Collaborators
Fractyl Laboratories, Inc.

Responsible Party: Fractyl Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02879383     History of Changes
Other Study ID Numbers: C-30000
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fractyl Laboratories, Inc.:
Type 2 Diabetes, Revita System, DMR

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases