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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 : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Fractyl Laboratories, Inc.

Brief Summary:

The Revita System is intended to improve glycemic control in patients with Type 2 diabetes who have preserved pancreatic beta cell function and whose diabetes is poorly controlled with oral anti-diabetic medications. 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 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

Detailed Description:

The study is a multi-center, randomized, prospective, double-blinded (subject and endocrinologist) trial of type 2 diabetes patients sub-optimally controlled on 2 oral anti-diabetic medications comparing the Fractyl DMR procedure to sham procedure. Subjects who meet all criteria after screening are randomized 1:1 (DMR to sham), with double blinding (subject and endocrinologist). The endoscopist is not blinded.

All subjects will participate in a 4 week oral anti-diabetic medication run-in period before the index procedure to confirm lack of blood glucose control in conjunction with medication compliance and nutritional counseling and to also allow withdrawal from hypoglycemic anti-diabetic medications (i.e. sulfonylurea and meglitinide classes). Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks.

Subjects randomized to the sham procedure are followed for 24 weeks and then offered to cross over to the DMR procedure. Cross-over subjects are then followed per protocol for an additional 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 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 : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DMR Procedure
Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks.
Procedure: DMR Procedure
The Fractyl DMR procedure using the Revita System utilizes an over the wire endoscopic approach to ablate the duodenum. The procedure may be completed in an endoscopic suite or in an operating room depending on the facilities and support at each investigative site. All subjects are monitored and anesthetized by conscious sedation per each facility's standard protocol. A full DMR procedure is defined as 5 complete ablations or 9 axial centimeters of circumferentially ablated tissue in the duodenum. Subjects who do not receive any ablations during the DMR procedure will be followed for safety through the 4 week visit and then discontinued from the study.
Other Names:
  • DMR
  • Revita

Sham Comparator: Sham Procedure
Unblinding to occur at 24 Weeks: Sham treatment arm to cross over to receive DMR treatment at 24 Weeks with background medications held constant from 24 - 48 Weeks of follow up.
Procedure: Sham Procedure
The sham procedure will consist of placing the Revita Catheter as described above into the duodenum and leaving it in place for a minimum of 45 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


Secondary Outcome Measures :
  1. Change in Magnetic Resonance Fat Fraction (MRFF) from baseline in the following at 12 weeks in DMR vs. Sham [ Time Frame: 12 Weeks post-procedure ]
    Magnetic Resonance Fat Fraction

  2. Change in Fasting Plasma Glucose (FPG) from baseline in the following at 24 weeks in DMR vs. Sham [ Time Frame: 24 Weeks post-procedure ]
    Fasting Plasma Glucose (FPG)

  3. Change in weight from baseline in the following at 24 weeks in DMR vs. Sham [ Time Frame: 24 Weeks post-procedure ]
    Weight

  4. Change in Fibrosis-4 Index for Liver Fibrosis (FIB-4) from baseline in the following at 24 weeks in DMR vs. Sham [ Time Frame: 24 Weeks post-procedure ]
    Fibrosis-4 Index for Liver Fibrosis (FIB-4)

  5. Change in Urine Albumin/Creatinine Ratio (UACR) from baseline in the following at 24 weeks in DMR vs. Sham [ Time Frame: 24 Weeks post-procedure ]
    Urine Albumin/Creatinine Ratio (UACR)

  6. Change in FPG from baseline in the following at 48 weeks in DMR subjects [ Time Frame: 48 Weeks post-procedure ]
    FPG

  7. Change in HbA1c from baseline in the following at 48 weeks in DMR subjects [ Time Frame: 48 Weeks post-procedure ]
    HbA1c



Information from the National Library of Medicine

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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. 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

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: Jay Caplan 781-902-8811 jay@fractyl.com
Contact: Aruna Vedala 781-325-8853 aruna@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.

Publications:
International Diabetes Federation (2014). The Global Burden. In IDF, International Diabetes Atlas (6th ed., pp 30).

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: April 25, 2018
Last Verified: April 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

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