- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02879383
Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussels, Belgium, 1070
- Hopital Erasme
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Leuven, Belgium
- UZ Leuven
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Sao Paulo, Brazil
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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São Paulo, Brazil
- ABC Hospital
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Milano, Italy, 20089
- Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano
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Lazio
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Rome, Lazio, Italy
- Policlinico Gemelli (Sacro Cuore)
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Amsterdam, Netherlands, 1105 AZ
- Amsterdam University Medical Center
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Glasgow, United Kingdom, G4 0SF
- Glasgow Royal Infirmary
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London, United Kingdom, NW1 2BU
- University College London Hospitals
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London, United Kingdom
- King's College, Denmark Hill
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Nottingham, United Kingdom, NG7 2UH
- Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DMR Procedure
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
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The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Other Names:
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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.
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The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham.
Time Frame: Baseline and 24 Weeks post-procedure
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The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham
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Baseline and 24 Weeks post-procedure
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Change From Baseline at 12 Weeks in MR-PDFF, DMR vs Sham
Time Frame: Baseline and 12 Weeks post-procedure
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The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF > 5% , DMR vs Sham
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Baseline and 12 Weeks post-procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Geltrude Mingrone, MD, PhD, Gemelli University Hospital, Rome
- Principal Investigator: Jacques Bergman, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-30000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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