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Type 2 DiabetesNCT03653091

Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes

A study testing Duodenal Mucosal Resurfacing (DMR) in people with Type 2 Diabetes, run by Fractyl Health Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. Read more about this study

Who is it for?
Ages 28 to 65 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Duodenal Mucosal Resurfacing (DMR)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
6 sitesUnited States
Study dates
28 Sep 2018to 10 Aug 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and non-pregnant women 28-65 years of age
  • Diagnosed with T2D for at least 3 years
  • A1C of 7.5 - 9.5% (59-80 mmol/mol)
  • BMI ≥ 28 and ≤ 40 kg/m2
  • On two to three oral OADs (metformin plus one to two additional OADs) with two (see note below) at least at half maximum labeled dose (or highest tolerated) with no changes in medication in the 12 weeks prior to the Screening Visit (Visit 1) (Refer to ADA Standard of Medical Care in Diabetes 2018, Table 8.3 for the maximum approved daily dose of non-insulin glucose lowering agents) (43). Note: For subjects on sulfonylurea (SU) glucose-lowering drugs for diabetes, the only SUs permitted in the study will be glipizide or glimepiride, and their doses below half maximum labeled dosing will not be an exclusion for study entry. Patients unwilling to reduce the dose of SU at the time of the DMR procedure as described by protocol will be excluded.
  • Agree to use an additional glucose-lowering treatment (eg, liraglutide, other OAD with the exception of glyburide) if recommended by the study investigator in case of persistent hyperglycemia.
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  • Agree not to donate blood during their participation in the study
  • Able to comply with study requirements and understand and sign the Informed Consent Form
  • Women of childbearing potential (WOCBP) must be using two acceptable methods of contraception throughout the study
  • Women must not be breastfeeding

Who cannot join

  • Diagnosed with Type 1 Diabetes (T1D)
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Probable insulin production failure, defined as fasting C Peptide serum <1 ng/mL (333pmol/l)
  • Previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes)
  • Current use of injectable medications for diabetes (insulin, GLP-1RA)
  • Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes
Show all 58Show fewer
  • 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, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  • Previous GI surgery that could limit treatment of the duodenum such as Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
  • History of chronic or acute pancreatitis
  • History of diabetic gastroparesis
  • Known active hepatitis or active liver disease
  • Acute gastrointestinal illness in the previous 7 days
  • Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
  • Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus
  • Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
  • Known history of a structural or functional disorder of the stomach including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach
  • Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety
  • Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the GI tract
  • Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
  • Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
  • History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
  • Current use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
  • Current use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure.
  • Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of low dose aspirin is allowed.
  • Current use of serotonergic medications (SSRI)
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit
  • Use of drugs known to affect GI motility (e.g. Metoclopramide)
  • Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
  • Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening
  • Persistent Anemia, defined as Hemoglobin <10 g/dL
  • Subjects who have donated blood or received a transfusion in the prior 3 months
  • Subjects with conditions that alter red blood cell turnover
  • Subjects with prosthetic joints
  • Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months
  • Moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD)
  • Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator
  • Active systemic infection
  • Active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma)
  • Subjects with a personal or family history of medullary thyroid carcinoma
  • Subjects with Multiple Endocrine Neoplasia syndrome type 2
  • Not a candidate for surgery or general anesthesia
  • Active illicit substance abuse or alcoholism
  • Current smoker
  • 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
  • Unwilling or unable to perform SMBG, complete the patient diary, or comply with study visits and other study procedures as required per protocol
  • Additional exclusion criteria to be confirmed during the screening process:
  • A1c post Run-In Phase < 7.5% (59 mmol/mol) or > 9.5% (86 mmol/mol)
  • Any severe hypoglycemic event, defined as hypoglycemia requiring third-party assistance; or any clinically significant hypoglycemic event, defined as self-monitored or laboratory plasma glucose level < 54 mg/dL (3.0 mmol/L); or ≥ 2 glucose alert values ≤70 mg/dL (3.9 mmol/L), unless a clear correctable precipitating factor can be identified, since the screening visit (Visit 1)
  • Uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15 mmol/L) after an overnight fast or >360 mg/dl (>20 mmol/l) in a randomly performed measurement during Medication Run-In Period and confirmed by a second measurement (not on the same day)
  • Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic)
  • WOCBP with a positive urine pregnancy test at Baseline Visit
  • Active and uncontrolled GERD defined as grade III esophagitis or greater
  • Abnormalities of the GI tract preventing endoscopic access to the duodenum
  • Anatomic abnormalities in the duodenum that would preclude the completion of the DMR procedure, including tortuous anatomy
  • Malignancy newly diagnosed by endoscopy
  • Upper gastrointestinal conditions such as ulcers, polyps, varices, strictures, congenital or acquired intestinal telangiectasia

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • UTHealth

    Houston, Texas, 77030

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Florida Hospital / TRANSLATIONAL RESEARCH INSTITUTE FOR METABOLISM AND DIABETES (TRI)

    Orlando, Florida, 32804

  • University of Pennsylvania - Penn Metabolic Medicine

    Philadelphia, Pennsylvania, 19104

  • Texas Diabetes Institute

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Sham-Controlled, Prospective, Multi-Center Pilot Study to Evaluate the Safety and Effectiveness of Duodenal Mucosal Resurfacing Using the Revita™ System in the Treatment of Type 2 Diabetes

The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment.

Read the detailed description

The study is a randomized, double-blind sham-controlled prospective multi-center clinical investigation of subjects with T2D sub-optimally controlled on two oral anti-diabetic medications, one of which must be metformin, comparing the Fractyl DMR procedure using the Revita™ System to a sham procedure. All subjects will participate in a 4 week oral anti-diabetic medication run-in period before the procedure to confirm inadequate blood glucose control in conjunction with medication compliance and nutritional counseling. Subjects who meet all criteria after screening are randomized 2:1 (DMR to sham), with double blinding (subject and endocrinologist/Sponsor). The endoscopist is not blinded.

Conditions
Type 2 Diabetes
Being tested
Duodenal Mucosal Resurfacing (DMR), Duodenal Mucosal Resurfacing Sham (Sham)
Keywords
Type 2 diabetes, Diabetes Mellitus, Noninsulin-Dependent Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Revita System, Anti-diabetic medications, Duodenal Mucosal Resurfacing
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duodenal Mucosal Resurfacing (DMR)Device

    The Fractyl DMR procedure utilizes the Revita™ Catheter to perform hydrothermal ablation of the duodenum. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DRM treatment are followed for 48 weeks while Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.

  • Duodenal Mucosal Resurfacing Sham (Sham)Device

    The Sham procedure consists of placing the Revita™ Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient.

Study groups in NCT03653091
Study groupRoleWhat they receive
Duodenal Mucosal Resurfacing (DMR)Active comparatorDuodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal mucosa in an upper endoscopic procedure in patients with type 2 diabetes.
Receives: Device: Duodenal Mucosal Resurfacing (DMR)
Duodenal Mucosal Resurfacing Sham (Sham)Sham comparatorDuodenal 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 type 2 diabetes.
Receives: Device: Duodenal Mucosal Resurfacing Sham (Sham)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin A1c (HbA1c)

    Change in HbA1c from baseline in DMR vs Sham groups

    Measured: 24 weeks post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start28 Sep 2018
  3. Primary completion10 Aug 2020
  4. Study completion10 Aug 2020

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03653091
Sponsor's protocol ID
C-40000
Status last verified
Feb 2024
First submitted
24 Aug 2018
Last updated
14 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Busch CBE, Meiring S, van Baar ACG, Gastaldelli A, DeFronzo R, Mingrone G, Hagen M, White K, Rajagopalan H, Nieuwdorp M, Bergman JJGHM. Insulin sensitivity and beta cell function after duodenal mucosal resurfacing: an open-label, mechanistic, pilot study. Gastrointest Endosc. 2024 Sep;100(3):473-480.e1. doi: 10.1016/j.gie.2024.01.031. Epub 2024 Jan 25.

    PubMed 38280531

Questions about this trial

What is this clinical trial studying?

A study testing Duodenal Mucosal Resurfacing (DMR) in people with Type 2 Diabetes, run by Fractyl Health Inc. at 6 sites in United States.

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 10 inclusion and 58 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 6 sites in United States. 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 26 Jul 2022). 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 in Hemoglobin A1c (HbA1c) (time frame: 24 weeks post procedure). 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 NCT03653091, 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.

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