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

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 1month
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 withsigned 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 Celiacdisease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma orother autoimmune connective tissue disorder
5. Previous GI surgery that could affect the ability to treat the duodenum such assubjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similarprocedures 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 duodenalinflammatory 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 cannotbe discontinued for 3-5 days before and 48 hours after the procedure and novel oralanticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannotbe discontinued for 48 hours before and 48 hours after the procedure in accordancewith the local protocol
11. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot bediscontinued for 5 days before and 48 hours after the procedure in accordance with thelocal protocol. Use of aspirin is allowed.
12. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatmentthrough 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 weightloss 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 ormyocardial infarction, heart failure, transient ischemic attack, or stroke within 6months 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 devicethat 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