Diabetes Mellitus, Type 2NCT02879383
Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
A study testing DMR Procedure in people with Diabetes Mellitus, Type 2 and Noninsulin-Dependent Diabetes Mellitus, run by Fractyl Health Inc. at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Noninsulin-Dependent Diabetes Mellitus
- What is being tested?
- DMR Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 1 Mar 2017to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 28-75 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
Who cannot join
- 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.)
Show all 24Show fewer
- 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)
- Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
- Persistent Anemia, defined as Hgb<10 g/dl
- Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Diseae (MDRD) <30 ml/min/1.73m^2
- Active systemic infection
- Active malignancy within the last 5 years
- Not potential candidates for surgery or general anesthesia
- Active illicit substance abuse or alcoholism
- Participating in another ongoing clinical trial of an investigational drug or device
- Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United Kingdom4 sites
Glasgow Royal Infirmary
Glasgow, G4 0SF
University College London Hospitals
London, NW1 2BU
King's College, Denmark Hill
London
Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road
Nottingham, NG7 2UH
Brazil2 sites
ABC Hospital
São Paulo
Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo
São Paulo
Italy2 sites
Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano
Milan, 20089
Policlinico Gemelli (Sacro Cuore)
Rome, Lazio
About this study
Official title: Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
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.
Read the 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 1 or more oral anti-diabetic medications comparing the Fractyl DMR procedure to sham procedure. Randomization will be 1:1 DMR treatment to sham. 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. The Sham treatment arm will cross-over to receive the DMR treatment at 24 weeks with background medications held constant 24weeks of follow up after the cross-over DMR procedure. The DMR treatment arm will be managed according to current diabetes standard of care.
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.
- Being tested
- DMR Procedure, Sham Procedure
- Keywords
- Type 2 Diabetes, Revita System, DMR
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMR ProcedureProcedure or surgery
Also called DMR, Revita
The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Sham ProcedureProcedure or surgery
The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
| Study group | Role | What they receive |
|---|---|---|
| DMR Procedure | Experimental | Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. Receives: 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. Receives: Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 12 Weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start1 Mar 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fractyl Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geltrude Mingrone, MD, PhD, Principal investigator, Gemelli University Hospital, RomeJacques Bergman, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879383
- Sponsor's protocol ID
- C-30000
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2016
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33597157
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
- ClinicalTrials.gov ID
- NCT02879383
- Acronym / sponsor ID
- C-30000
- Keywords
- Type 2 Diabetes, Revita System, DMR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Fractyl Health Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 1 or more oral anti-diabetic medications comparing the Fractyl DMR procedure to sham procedure. Randomization will be 1:1 DMR treatment to sham. 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. The Sham treatment arm will cross-over to receive the DMR treatment at 24 weeks with background medications held constant 24weeks of follow up after the cross-over DMR procedure. The DMR treatment arm will be managed according to current diabetes standard of care.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMR Procedure | Experimental | Procedure: DMR ProcedureSubjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. |
| Sham Procedure | Sham comparator | Procedure: Sham ProcedureSubjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. |
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 28-75 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMR ProcedureAlso: DMR, RevitaThe DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System | Procedure or surgery | DMR Procedure |
| Sham ProcedureThe sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient. | Procedure or surgery | Sham Procedure |
Primary outcome
Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham.
Time frame: Baseline and 24 Weeks post-procedure
The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham
Change From Baseline at 12 Weeks in MR-PDFF, DMR vs Sham
Time frame: Baseline and 12 Weeks post-procedure
The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF > 5% , DMR vs Sham
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33597157Mingrone 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geltrude Mingrone, MD, PhD principal investigator
Gemelli University Hospital, Rome
Jacques Bergman, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMR Procedure in people with Diabetes Mellitus, Type 2 and Noninsulin-Dependent Diabetes Mellitus, run by Fractyl Health Inc. at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Belgium, Brazil, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham. (time frame: Baseline and 24 Weeks post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.