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

Diabetes Mellitus, Type 2 Clinical Trial

— EMINENT-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984238
• Other study ID #: NL83266.000.22
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Celine BE Busch, MD
• Phone: +31621357593
• Email: c.b.busch[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the Gen-2 catheter) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.

Description:

The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (ReCET system by the Endogenex with the Gen-2 catheter) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• ReCET
Investigational product.

Drug:
• Semaglutide, 1.0 mg/mL
Already registered medicine for type 2 diabetes

Other:
• Sham procedure
The sham control for the ReCET procedure.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	North-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Endogenex

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]	The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post ReCET procedure.	24 weeks
Primary	Percentage of patients off insulin at 24 weeks [efficacy]	Percentage of patients free of insulin at 24 weeks post ReCET with an HbA1c = 58 mmol/mol compared to sham.	24 weeks
Secondary	Secondary safety endpoint 1 - hypoglycemic events	Number of hypoglycemic events	Through study completion (1 to 1,5 year)
Secondary	Secondary safety endpoint 2 - SAEs	All SAEs	Through study completion (1 to 1,5 year)
Secondary	Secondary feasibility endpoint 1 - technical success rate	Technical success rate, defined as percentage of subjects successfully completed the ReCET procedure (defined as = 3 ablations).	24 weeks (after cross-over)
Secondary	Secondary feasibility endpoint 2 - GLP-1RA tolerability	Percentage of subjects adequately using and tolerating GLP-1RA (semaglutide).	Through study completion (1 to 1,5 year)
Secondary	Secondary efficay endpoint 1 - HbA1c 48 weeks	Protocol driven number of subjects free of insulin at 48 weeks, including an HbA1c = 58 mmol/mol.	at 48 weeks

External Links

•   Website for people that are interested in participating.