Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Di… (NCT06092476) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients
Netherlands18 participantsStarted 2024-08-09
Plain-language 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 non-insulin glucose lowering medications.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety endpoint
Timeframe: 12 weeks post DMR and 12 weeks post retreatment with DMR
2
Feasibility endpoint 1
Timeframe: During procedure
3
Feasibility endpoint 2
Timeframe: During procedure
4
Efficacy endpoint 1
Timeframe: 24 weeks post DMR/sham
5
Efficacy endpoint 2
Timeframe: 24 weeks post DMR/sham
Trial details
NCT IDNCT06092476
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
. 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.
. 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).