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EMINENT-2

Active not recruitingPhase NA

A Trial to Evaluate Safety, Feasibility and Efficacy of the ReCET Procedure (EMINENT-2)

Endoscopic Application of Pulsed Electric Fields Using by the Endogenex Generation 2 ReCET 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

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

32

estimated

Study population

Type 2 diabetes

Key I/E criterion

BMI 24-42

Primary endpoints

Serious AEs (any) (Serious AEs (any))Percentage of patients off insulin

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05984238
Org study IDNL83266.000.22

Timeline

Milestones

Study start2023-08-03actual
Study first posted2023-08-09actual
Primary completion2025-03-21actual
Last update posted2026-01-15actual
Study completion2026-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age28 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Diagnosed with type 2 diabetes mellitus

2. 28 - 75 years of age

3. On daily long acting insulin dose ≤ 1 U/kg, with a stable dose (within 10%) over 1 month

4. BMI ≥ 24 and ≤ 42 kg/m2

5. HbA1c ≤ 64 mmol/mol (8.0%)

6. Fasting C-peptide ≥ 0.2 nmol/L (0.6 ng/ml)

7. Willing to comply with study requirements and able to understand and comply with signed informed consent

Exclusion criteria

1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis

2. Current use of multiple daily doses insulin or insulin pump.

3. Current or within the last 3 months use of a GLP-1 analogue.

4. 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

5. 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

6. History of chronic or acute pancreatitis

7. Known active hepatitis or active liver disease

8. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease

9. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia

10. 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

11. 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.

12. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase

13. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)

14. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications

15. Anemia, defined as Hgb < 6.2 mmol/l

16. Known history of severe permanent cardiac arrhythmia's with clinical symptoms

17. 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

18. With any implanted electronic devices or duodenal metallic implants

19. eGFR or MDRD < 30 ml/min/1.73m^2

20. Active systemic infection

21. Active malignancy within the last 5 years

22. Not potential candidates for surgery or general anesthesia

23. Active illicit substance abuse or alcoholism

24. Pregnancy or wish getting pregnant in next year

25. Participating in another ongoing clinical trial of an investigational drug or device that can interfere with the current study.

26. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
4
Glycemic / diabetes
2
Other clinical outcomes
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Percentage of patients off insulin at 24 weeks [efficacy]

Time frame:24 weeks

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Secondary efficay endpoint 1 - HbA1c 48 weeks

Time frame:at 48 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]

Time frame:24 weeks

Serious AEs (any)

event count, event

componentsSerious AEs (any)

Secondary/protocol endpoint

Secondary safety endpoint 1 - hypoglycemic events

Time frame:Through study completion (1 to 1,5 year)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Secondary safety endpoint 2 - SAEs

Time frame:Through study completion (1 to 1,5 year)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Secondary feasibility endpoint 2 - GLP-1RA tolerability

Time frame:Through study completion (1 to 1,5 year)

threshold achievement, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Secondary feasibility endpoint 1 - technical success rate

Time frame:24 weeks (after cross-over)

threshold achievement, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.