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Diabetes Mellitus, Type 2REMINDNCT06092476

Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients

A study testing Revita® DMR Treatment in people with Diabetes Mellitus, Type 2, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Revita® DMR Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteNetherlands
Study dates
9 Aug 2024to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with Type 2 Diabetes.
  • Age ≥ 18 to ≤ 75 years.
  • 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.
  • BMI ≥ 24 and ≤ 40 kg/m2
  • HbA1c of ≥ 54 mmol/mol (7.5%) and ≤ 86 mmol/mol (10.0%).
  • Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.

Who cannot join

  • 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.
  • Subjects who are using insuline.
  • Known case of absolute insulin deficiency as indicated by a fasting plasma C-peptide value of <0.6 ng/ml (<0,2 nmol/L).
  • 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).
  • History of more than 1 severe hypoglycemia episode or unawareness within past 6 months in which third party assistance was needed.
  • Clinically significant valvular heart disease or severe aortic stenosis.
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  • 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.
  • 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).
  • 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.
  • Impaired renal function, defined as estimated Glomerular Filtration rate (eGFR) < 45 ml/min/1.73m2 or end stage renal failure or on dialysis.
  • Diagnosed with esophageal motility disorder or Glomerular Filtration rate (GERD) gr 3 or diagnosed during screening endoscopy.
  • 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.
  • 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.
  • 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.
  • Patients with active helicobacter pylori infection. Patients may be enrolled if they had history of h-pylori infection and were successfully treated.
  • 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.
  • Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cells (sickle cell trait is allowed).
  • Known case of severe peripheral vascular disease.
  • Clinically active systemic infection.
  • 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.
  • Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to consent or any other uncontrolled endocrine disorder.
  • 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.
  • Actively participating in weight loss program or using medications for weight loss 3 months prior to randomization.
  • 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.
  • Nursing or Pregnant women or women of child bearing potential who are unwilling to practice acceptable method of birth control.
  • History of alcohol, legal or illegal drug and substance abuse.
  • 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.
  • Any other clinical or mental condition which would jeopardize subject's safety or makes subject a poor candidate for clinical trial participation.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Amsterdam UMC, locatie VUmc

    Amsterdam

Other trials in Netherlands

About this study

Official title: 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)

The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.

Read the detailed description

The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.

The aimed effect is an adequate or improved glucose regulation and a decrease of HbA1c. Secondary effects include improved cardiovascular, hepatic, and metabolic parameters.

Being tested
Revita® DMR Treatment, Sham procedure
Keywords
Type 2 Diabetes, Duodenal ablation, Endoscopy, Duodenal Mucosal Resurfacing
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.

  • Revita® DMR TreatmentDevice

    Also called Revita® DMR Treatment Paradigm 1, Revita Duodenal Mucosal Resurfacing

    The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows:

    DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner.

  • Sham procedureOther

    The sham control for the Revita DMR procedure.

Study groups in NCT06092476
Study groupRoleWhat they receive
DMR procedureActive comparatorPatients receive Revita® DMR Treatment Paradigm 1. After unblinding at 24 weeks, they receive retreatment.
Receives: Device: Revita® DMR Treatment
Sham procedureSham comparatorPatients receive a sham procedure. After unblinding takes place at 24 weeks, patients receive a Revita® DMR Treatment Paradigm 1. 48 weeks after initial sham (= 24 weeks after first DMR) patients may receive retreatment, if they want to.
Receives: Other: Sham procedure

What is being measured

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

  1. Safety endpoint

    Safety endpoint is evaluated 12 weeks post DMR and 12 weeks post retreatment with DMR

    • Number (percentage) of patients experienced device and procedure-related Serious Adverse Events (SAEs), Unanticipated Device Effects (UADEs), Serious Adverse Device Effects (SADEs), Suspected Unexpected Serious Adverse Reaction (SUSARs)

    Measured: 12 weeks post DMR and 12 weeks post retreatment with DMR

  2. Feasibility endpoint 1

    Feasibility endpoint is evaluated during and after the procedure:

    • Number of ablations, whether a DMR was successful (>3 ablations)

    Measured: During procedure

  3. Feasibility endpoint 2

    Feasibility endpoint is evaluated during and after the procedure:

    • Procedure time, defined as time between catheter in and catheter out.

    Measured: During procedure

  4. Efficacy endpoint 1

    Efficacy is evaluated at 24 weeks compared to baseline and sham:

    • Mean change in Fasting Plasma Glucose (FPG)/Flash Glucose Monitoring (FGM)

    Measured: 24 weeks post DMR/sham

  5. Efficacy endpoint 2

    Efficacy is evaluated at 24 weeks compared to baseline and sham:

    • Change in HbA1c

    Measured: 24 weeks post DMR/sham

Secondary outcomes (20)

  1. Secondary safety endpoint

    Secondary safety endpoint is evaluated during follow-up and compared to baseline and sham at week 24 and compared to baseline and 12 weeks after (re)-DMR for all patients: incidences and event rates of hypoglycemic events during complete study period

    Measured: Through study completion, an average of 1 or 1,5 years

  2. Efficacy endpoint 1: mean change in HbA1c

    Efficacy endpoint 1: mean change in HbA1c

    Measured: Through study completion, an average of 1 or 1,5 years

  3. Efficacy endpoint 2: mean Change in Fasting Glucose

    Efficacy endpoint 2: mean Change in Fasting Glucose

    Measured: Through study completion, an average of 1 or 1,5 years

  4. Efficacy endpoint 2: mean Change in Time in Range (TIR)

    Efficacy endpoint 2: mean Change in Time in Range

    Measured: Through study completion, an average of 1 or 1,5 years

  5. Efficacy endpoint 3: In patients with baseline abnormal Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) values, change in ALT, AST, GGT

    Efficacy endpoint 3: In patients with baseline abnormal ALT, AST and GGT values, change in ALT, AST, GGT

    Measured: Through study completion, an average of 1 or 1,5 years

  6. Efficacy endpoint 4: Change in body weight

    Efficacy endpoint 4: Change in body weight

    Measured: Through study completion, an average of 1 or 1,5 years

  7. Efficacy endpoint 5: Change in Fasting C-peptide

    Efficacy endpoint 5: Change in Fasting C-peptide

    Measured: Through study completion, an average of 1 or 1,5 years

  8. Efficacy endpoint 6: Change in FPG

    Efficacy endpoint 6: Change in FPG

    Measured: Through study completion, an average of 1 or 1,5 years

  9. Efficacy endpoint 7: Change in homeostasis model assessment for insulin resistance (HOMA-IR)

    Efficacy endpoint 7: Change in HOMA-IR

    Measured: Through study completion, an average of 1 or 1,5 years

  10. Efficacy endpoint 8: Change in Framingham Risk Score-Cardiovascular risk score (FRS-CVD)

    Efficacy endpoint 8: Change in Framingham Risk Score-Cardiovascular risk score (FRS-CVD)

    Measured: Through study completion, an average of 1 or 1,5 years

  11. Efficacy endpoint 9: Change in MRI-proton density fat fraction (MRI-PDFF)

    Efficacy endpoint 9: Change in MRI-PDFF

    Measured: Through study completion, an average of 1 or 1,5 years

  12. Efficacy endpoint 10: Achievement of HbA1c ≤ 53 mmol/mol (7.0%)

    Efficacy endpoint 10: Achievement of HbA1c ≤ 53 mmol/mol (7.0%)

    Measured: Through study completion, an average of 1 or 1,5 years

  13. Efficacy endpoint 11: Change in food intake (amount of calories, fat, carbohydrates, proteins etc.) based on intake registration data

    Efficacy endpoint 11: Change in food intake (amount of calories, fat, carbohydrates, proteins etc.) based on intake registration data

    Measured: Through study completion, an average of 1 or 1,5 years

  14. Mechanistic: Change in resection tissue findings in morphological features

    Mechanistic: Change in morphological features

    Measured: Week 12 after (re)DMR

  15. Mechanistic: Change in resection tissue findings in functional level changes

    Mechanistic: Change in functional level changes

    Measured: Week 12 after (re)DMR

  16. Mechanistic: Change in resection tissue findings in cellular level changes

    Mechanistic: Change in cellular level changes

    Measured: Week 12 after (re)DMR

  17. Mechanistic: Mean Changes in small intestinal biopsy gene expression

    Mechanistic: Mean Changes in small intestinal biopsy gene expression

    Measured: Week 12 after (re)DMR

  18. Mechanistic: Mean Changes in small intestinal biopsy metabolomics/proteomics

    Mechanistic: Mean Changes in small intestinal biopsy metabolomics /proteomics

    Measured: Week 12 after (re)DMR

  19. Mechanistic: Change in Plasma Citrulline

    Mechanistic: Change in Plasma Citrulline

    Measured: Through study completion, an average of 1 or 1,5 years

  20. Mechanistic: Change in Cystatin Value

    Mechanistic: Change in Cystatin Value

    Measured: Through study completion, an average of 1 or 1,5 years

Timeline

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

  1. First posted23 Oct 2023
  2. Study start9 Aug 2024
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

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
Crossover
Model description
The study is a single-center, randomized, double-blind, sham-controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06092476
Sponsor's protocol ID
NL82963.018.23
Acronym
REMIND
Status last verified
Aug 2026
First submitted
22 Sep 2023
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Revita® DMR Treatment in people with Diabetes Mellitus, Type 2, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

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 28 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

This study is still under way. Results are not available in the source record yet.

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?

Safety endpoint (time frame: 12 weeks post DMR and 12 weeks post retreatment with DMR). The study lists 5 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 NCT06092476.

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 6 Aug 2026.

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