Revita DMR with optional retreatment for type 2 diabetes

A Randomized Double-blind Sham-controlled Trial to Evaluate Efficacy+Safety of Revita Duodenal Mucosal Resurfacing (DMR) Treatment Paradigm+Retreatment in Patients With Type 2 Diabetes Using Non-insulin Glucose Lowering Medications (REMIND)

This trial tests whether endoscopic Revita duodenal mucosal resurfacing (DMR), with or without a retreatment at 24 weeks, can improve blood sugar control in adults with type 2 diabetes who are not using insulin.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Amsterdam)
• Trial ID: NCT06092476 on ClinicalTrials.gov

What this trial studies

Adults with type 2 diabetes who are insulin‑naive and on stable non‑insulin glucose‑lowering medications undergo endoscopic duodenal mucosal resurfacing (Revita DMR) or a sham procedure to compare safety, feasibility, and effects on glycemic control. The protocol includes an evaluation of retreatment at 24 weeks to see whether a second DMR adds benefit compared with a single procedure and baseline. Primary outcomes focus on changes in HbA1c and procedure safety, with secondary measures including cardiovascular, liver, and broader metabolic parameters. Procedures are performed at a single academic center and participants are followed longitudinally for clinical and laboratory endpoints.

Who should consider this trial

Good fit: Adults aged 18–75 with type 2 diabetes who are insulin‑naive, on a stable regimen of two or more non‑insulin glucose‑lowering drugs for at least 12 weeks, with BMI 24–40 kg/m2 and HbA1c 7.5–10.0% are the intended participants.

Not a fit: People who use insulin, have uncontrolled fasting hyperglycemia (>270 mg/dL), evidence of insulin deficiency, or who fall outside the BMI or HbA1c eligibility ranges are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the procedure could lower HbA1c and improve glucose regulation and cardiometabolic markers, potentially reducing reliance on medications for some patients.

How similar studies have performed: Prior smaller DMR studies have shown promising reductions in HbA1c and metabolic improvements, but larger confirmatory data and evidence on routine retreatment remain limited.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with Type 2 Diabetes.
2. Age ≥ 18 to ≤ 75 years.
3. Insulin naïve patients who are on stable dose (maximally approved or tolerated dose) of 2 or more glucose lowering drugs, including metformin, sulphonylurea (SU), (sodium-glucose cotransporter-2) inhibitors (SGLT-2i), Glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase 4 inhibitor (DPP-4i) and/or, thiazolidinedionderivaten (TZD) for at least 12 weeks.
4. BMI ≥ 24 and ≤ 40 kg/m2
5. HbA1c of ≥ 54 mmol/mol (7.5%) and ≤ 86 mmol/mol (10.0%).
6. Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion Criteria:

1. Uncontrolled hyperglycemia with a glucose level \>270 mg/dl (\>15.0 mmol/L) after an overnight 8-hour fasting at the end of run-in and confirmed by a second measurement on the consecutive day.
2. Subjects who are using insuline.
3. Known case of absolute insulin deficiency as indicated by a fasting plasma C-peptide value of \<0.6 ng/ml (\<0,2 nmol/L).
4. Diagnosis of autoimmune diabetes/Type 1 diabetes mellitus, monogenic (neonatal or maturity onset diabetes of the young (MODY)) diabetes or Type 1 diabetes in adults/latent autoimmune diabetes of adults (LADA).
5. History of more than 1 severe hypoglycemia episode or unawareness within past 6 months in which third party assistance was needed.
6. Clinically significant valvular heart disease or severe aortic stenosis.
7. Acute coronary syndrome (non-ST wave elevated myocardial infarction (STEMI), STEMI and unstable angina pectoris), stroke or transient ischemic attack within the past 3 months.
8. Indication of acute liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN).
9. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis; or hepatic decompensation during the last 6 months; or alcoholic or autoimmune chronic hepatitis.
10. Impaired renal function, defined as estimated Glomerular Filtration rate (eGFR) \< 45 ml/min/1.73m2 or end stage renal failure or on dialysis.
11. Diagnosed with esophageal motility disorder or Glomerular Filtration rate (GERD) gr 3 or diagnosed during screening endoscopy.
12. Known history of a structural or functional disorder of the stomach, e.g. active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia, stomach cancer or any other disorder of the stomach.
13. Previous GI surgery that could affect the ability to treat the duodenum such as patients who have had a Billroth 2, Roux-and-Y gastric bypass, gastric sleeve or other similar procedures.
14. Known intestinal autoimmune disease, including Celiac disease, or pre-existing symptoms of lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder, which affects the small intestine.
15. Patients with active helicobacter pylori infection. Patients may be enrolled if they had history of h-pylori infection and were successfully treated.
16. History of active malignancy or partial remission from clinically significant malignancy within the past 5 years. With the exception of basal or squamous cell skin cancer or carcinoma in situ or those received curative treatment and in complete remission for 5 years or if subject confirmed as cancer free.
17. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cells (sickle cell trait is allowed).
18. Known case of severe peripheral vascular disease.
19. Clinically active systemic infection.
20. Known immunocompromised status, including individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, clinically significant leukopenia or positive for the human immunodeficiency virus (HIV), on potential immunosuppressants.
21. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to consent or any other uncontrolled endocrine disorder.
22. Use of anticoagulation therapy (such as warfarin, coumadin, Novel Oral AntiCoagulants (NOAC) or anti-platelet agents (such as thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure; Acetylsalicylic acid does not need to be discontinued.
23. Actively participating in weight loss program or using medications for weight loss 3 months prior to randomization.
24. General contraindications to deep or conscious sedation or general anesthesia or high risk (e.g., American Society of Anesthesiologists Classification (ASA) 4 or higher) or contraindications to upper GI Endoscopy.
25. Nursing or Pregnant women or women of child bearing potential who are unwilling to practice acceptable method of birth control.
26. History of alcohol, legal or illegal drug and substance abuse.
27. Intake of an investigational drug in another trial within 30 days prior to consent or active participation in another clinical trial of an investigational drug or device.
28. Any other clinical or mental condition which would jeopardize subject's safety or makes subject a poor candidate for clinical trial participation.

Where this trial is running

Amsterdam

• Amsterdam UMC, locatie VUmc — Amsterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Jacques JG Bergman, MD, PhD — Amsterdam UMC
• Study coordinator: Kim van den Hoek, MD

Conditions Diabetes Mellitus, Type 2; Type 2 Diabetes; Duodenal ablation; Endoscopy; Duodenal Mucosal Resurfacing