Diabetes Mellitus, Type 2EMINENT-2NCT05984238
A Trial to Evaluate Safety, Feasibility and Efficacy of Endoscopic Duodenal PEF Therapy
A study testing PEF therapy using the Endogenex Device and Semaglutide, 1.0 mg/mL in people with Diabetes Mellitus, Type 2, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 28 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- PEF therapy using the Endogenex Device and Semaglutide, 1.0 mg/mL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Aug 2023to 28 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus
- 28 - 75 years of age
- On daily long acting insulin dose ≤ 1 U/kg, with a stable dose (within 10%) over 1 month
- BMI ≥ 24 and ≤ 42 kg/m2
- HbA1c ≤ 64 mmol/mol (8.0%)
- Fasting C-peptide ≥ 0.2 nmol/L (0.6 ng/ml)
- Willing to comply with study requirements and able to understand and comply with signed informed consent
Who cannot join
- Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
- Current use of multiple daily doses insulin or insulin pump.
- Current or within the last 3 months use of a GLP-1 analogue.
- Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- 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
Show all 26Show fewer
- 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 phenprocoumon and acenocoumarol) which cannot be discontinued for 3-5 days before and 48 hours after the procedure and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 48 hours before and 48 hours after the procedure in accordance with the local protocol
- Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 5 days before and 48 hours after the procedure in accordance with the local protocol. 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
- Anemia, defined as Hgb < 6.2 mmol/l
- Known history of severe permanent cardiac arrhythmia's with clinical symptoms
- Significant cardiovascular disease, including known history of valvular disease or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the screening visit
- With any implanted electronic devices or duodenal metallic implants
- eGFR or 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
- Pregnancy or wish getting pregnant in next year
- Participating in another ongoing clinical trial of an investigational drug or device that can interfere with the current study.
- Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Application of Pulsed Electric Fields Using the Endogenex Generation 2 System for Duodenal Mucosal Regeneration for EliMination of INsulin in the treatmENT of Type 2 Diabetes: a Randomized Double-blind Sham Controlled Trial to Evaluate Safety, Feasibility and Efficacy Study
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.
Read the detailed description
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus and an adequate beta cell reserve in a randomized sham-controlled study. The aimed effect is an adequate or improved glucose regulation without the need for insulin therapy. Secondary effects include improved cardiovascular, hepatic, and metabolic parameters.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PEF therapy using the Endogenex Device, Semaglutide, 1.0 mg/mL, Sham procedure
- Keywords
- Type 2 Diabetes, Duodenal ablation, Endoscopy, Electroporation
- 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.
PEF therapy using the Endogenex DeviceDevice
Investigational product.
Semaglutide, 1.0 mg/mLDrug
Already registered medicine for type 2 diabetes
Sham procedureOther
The sham control for the PEF therapy procedure.
| Study group | Role | What they receive |
|---|---|---|
| PEF therapy procedure | Active comparator | Patients receive endoscopic duodenal PEF therapy, which is performed using the Endogenex device.
After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started. Receives: Device: PEF therapy using the Endogenex Device; Drug: Semaglutide, 1.0 mg/mL |
| Sham procedure | Sham comparator | Patients receive sham procedure, this consists of placing an Endogenex catheter, or a catheter with a similar circumference at the endoscopists discretion in the stomach and leaving it in place for 30 minutes.
After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started Receives: Drug: Semaglutide, 1.0 mg/mL; Other: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]
The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post PEF therapy procedure.
Measured: 24 weeks
Percentage of patients off insulin at 24 weeks [efficacy]
Percentage of patients free of insulin at 24 weeks post PEF therapy with an HbA1c ≤ 58 mmol/mol compared to sham.
Measured: 24 weeks
Secondary outcomes (5)
Secondary safety endpoint 1 - hypoglycemic events
Number of hypoglycemic events
Measured: Through study completion (1 to 1,5 year)
Secondary safety endpoint 2 - SAEs
All SAEs
Measured: Through study completion (1 to 1,5 year)
Secondary feasibility endpoint 1 - technical success rate
Technical success rate, defined as percentage of subjects successfully completed the PEF therapy procedure (defined as ≥ 3 ablations).
Measured: 24 weeks (after cross-over)
Secondary feasibility endpoint 2 - GLP-1RA tolerability
Percentage of subjects adequately using and tolerating GLP-1RA (semaglutide).
Measured: Through study completion (1 to 1,5 year)
Secondary efficay endpoint 1 - HbA1c 48 weeks
Protocol driven number of subjects free of insulin at 48 weeks, including an HbA1c ≤ 58 mmol/mol.
Measured: at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start3 Aug 2023
- Primary completion21 Mar 2025
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This study is a single-center, double-blind, sham-controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Endogenex
- Responsible party
- Principal investigator, Jacques J.G.H.M. Bergman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jacques JG Bergman, MD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984238
- Sponsor's protocol ID
- NL83266.000.22
- Acronym
- EMINENT-2
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 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
Publications
Busch CBE, van den Hoek K, Neefjes-Borst EA, Nieuwdorp M, van Baar ACG, Bergman JJHGM. Optimizing duodenal tissue acquisition for mechanistic studies of duodenal ablation in type 2 diabetes. Endosc Int Open. 2025 Jan 29;13:a25032135. doi: 10.1055/a-2503-2135. eCollection 2025.
PubMed 40007651Musso G, Pinach S, Saba F, De Michieli F, Cassader M, Gambino R. Endoscopic duodenal mucosa ablation techniques for diabetes and nonalcoholic fatty liver disease: A systematic review. Med. 2024 Jul 12;5(7):735-758.e2. doi: 10.1016/j.medj.2024.03.014. Epub 2024 Apr 4.
PubMed 38579730
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Application of Pulsed Electric Fields Using the Endogenex Generation 2 System for Duodenal Mucosal Regeneration for EliMination of INsulin in the treatmENT of Type 2 Diabetes: a Randomized Double-blind Sham Controlled Trial to Evaluate Safety, Feasibility and Efficacy Study
- ClinicalTrials.gov ID
- NCT05984238
- Acronym / sponsor ID
- EMINENT-2 / NL83266.000.22
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes, Duodenal ablation, Endoscopy, Electroporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Endogenex
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.
Detailed description
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus and an adequate beta cell reserve in a randomized sham-controlled study. The aimed effect is an adequate or improved glucose regulation without the need for insulin therapy. Secondary effects include improved cardiovascular, hepatic, and metabolic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-center, double-blind, sham-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| PEF therapy procedure | Active comparator | Device: PEF therapy using the Endogenex Device, Drug: Semaglutide, 1.0 mg/mLPatients receive endoscopic duodenal PEF therapy, which is performed using the Endogenex device. After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started. |
| Sham procedure | Sham comparator | Drug: Semaglutide, 1.0 mg/mL, Other: Sham procedurePatients receive sham procedure, this consists of placing an Endogenex catheter, or a catheter with a similar circumference at the endoscopists discretion in the stomach and leaving it in place for 30 minutes. After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started |
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with type 2 diabetes mellitus
- 28 - 75 years of age
- On daily long acting insulin dose ≤ 1 U/kg, with a stable dose (within 10%) over 1 month
- BMI ≥ 24 and ≤ 42 kg/m2
- HbA1c ≤ 64 mmol/mol (8.0%)
Key exclusion criteria (26 listed)
- Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
- Current use of multiple daily doses insulin or insulin pump.
- Current or within the last 3 months use of a GLP-1 analogue.
- Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEF therapy using the Endogenex DeviceInvestigational product. | Device | PEF therapy procedure |
| Semaglutide, 1.0 mg/mLAlready registered medicine for type 2 diabetes | Drug | PEF therapy procedure, Sham procedure |
| Sham procedureThe sham control for the PEF therapy procedure. | Other | Sham procedure |
Primary outcome
Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]
Time frame: 24 weeks
The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post PEF therapy procedure.
Percentage of patients off insulin at 24 weeks [efficacy]
Time frame: 24 weeks
Percentage of patients free of insulin at 24 weeks post PEF therapy with an HbA1c ≤ 58 mmol/mol compared to sham.
5 secondary outcomes
Secondary safety endpoint 1 - hypoglycemic events
Time frame: Through study completion (1 to 1,5 year)
Secondary safety endpoint 2 - SAEs
Time frame: Through study completion (1 to 1,5 year)
Secondary feasibility endpoint 1 - technical success rate
Time frame: 24 weeks (after cross-over)
Secondary feasibility endpoint 2 - GLP-1RA tolerability
Time frame: Through study completion (1 to 1,5 year)
Secondary efficay endpoint 1 - HbA1c 48 weeks
Time frame: at 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 40007651Busch CBE, van den Hoek K, Neefjes-Borst EA, Nieuwdorp M, van Baar ACG, Bergman JJHGM. Optimizing duodenal tissue acquisition for mechanistic studies of duodenal ablation in type 2 diabetes. Endosc Int Open. 2025 Jan 29;13:a25032135. doi: 10.1055/a-2503-2135. eCollection 2025.
- Derived from this study: PubMed 38579730Musso G, Pinach S, Saba F, De Michieli F, Cassader M, Gambino R. Endoscopic duodenal mucosa ablation techniques for diabetes and nonalcoholic fatty liver disease: A systematic review. Med. 2024 Jul 12;5(7):735-758.e2. doi: 10.1016/j.medj.2024.03.014. Epub 2024 Apr 4.
- Website for people that are interested in participating.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques JG Bergman, MD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEF therapy using the Endogenex Device and Semaglutide, 1.0 mg/mL 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 7 inclusion and 26 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety] (time frame: 24 weeks). The study lists 2 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 NCT05984238, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 7 Nov 2026.