ReCET
A Multicenter, Randomized, Double-blind, Sham-controlled study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals with Type II Diabetes (ReCET Study)
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Clinical Trial Information
Trial Contact: Morales, Leticia; Galvoa Neto, Manoel; Hernandez-Pagan, Gloryvee
Trial Phone: 321.841.9623 ; 321.843.8900 ; 321-843-8910
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IRB No: W24.029.02
Protocol Abbrev: ReCET
Principal Investigator: Andre F. Teixeira, MD
Phase: Device: Phase III
Age Group: Adult
Secondary Protocol No: 898
Treatment: ReCET System or Sham
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT06267391
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Objective
Primary: To demonstrate that the ReCET therapy is superior to sham therapy for improving glycemic control in adults with type 2 diabetes inadequately controlled on non-insulin glucose-lowering medications
Key Secondary: To assess the durability of the response to ReCET therapy at 12 months
Secondary (controlled for Type I error)
• To assess proportion of participants achieving glycemic control target at 6 months
• To assess proportion of participants achieving Time-In-Range target at 6 months
• To assess weight loss at 6 months
Exploratory
• To explore changes in glycemic control by visits
• To explore changes in weight and lipid profile
• To explore the technical performance of the ReCET procedure
• To explore the impact of treatment on participant’s diabetes-related quality of life -
Key Eligibility
Inclusion Criteria
Participants are eligible to be included in the study if all of the following criteria apply:
1. 22-70 years of age, inclusive.
2. T2D diagnosis for at least 6 months.
3. HbA1c of 7.5-10.5%, inclusive, determined by central laboratory.
4. BMI 27-40 kg/m2, inclusive.
5. On 2-4 non-insulin glucose lowering mediations, with no changes in medication or dosing for at
least 12 weeks prior to the baseline visit.
6. Individualized metabolic surgery (IMS) score ≤ 95.
7. Weight stability (defined as a < 5% change in body weight) for at least 12 weeks prior to the
screening visit.
8. Agree not to donate blood during participation in the study.
9. Able to comply with study requirements and understand and sign the Informed Consent Form.
10. Women of childbearing potential must be not pregnant and using an acceptable method of
contraception throughout the study.
11. Willing and able to comply with study visits and study tasks as required per protocol.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1. Diagnosed with type 1 diabetes.
2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
3. Fasting C-peptide serum <1 ng/mL (333pmol/l).
4. Current use of insulin, or previous use of any types of insulin for >1 month at any time (except for
treatment of gestational diabetes) in last 2 years.
5. Hypoglycemia unawareness.
6. History of ≥1 severe hypoglycemia episode in the past 6 months.
7. Discontinuation of a GLP-1RA or a GLP-1/GIP dual-agonist within 6 months of the screening visit
following at least one month of treatment.
8. Known autoimmune disease, including but not limited to, celiac disease, or pre-existing symptoms
of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder as
evidenced by a positive anti-glutamic acid decarboxylase (GAD) test.
9. Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such
as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
10. Known history of a structural or functional disorder of the upper GI tract that may impede passage
of the device through the upper GI tract or increase risk of tissue damage during an endoscopic
procedure, including eosinophilic esophagitis, stricture/stenosis, varices, diverticula, or other
disorder of the esophagus, stomach and duodenum.
11. History of gastroparesis.
12. Acute gastrointestinal illness in the previous 7 days.
13. Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel
disease, such as Crohn's disease and Celiac disease.
14. History of chronic or acute pancreatitis.
15. Known active hepatitis or active liver disease, or alanine aminotransferase (ALT) level >3.0 times
the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at
study entry. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.
16. Current use of anticoagulation therapy (such as warfarin) that cannot be safely discontinued
periprocedurally.
17. Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for
7 days before the procedure.
18. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through
4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
19. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for
more than 10 consecutive days within 12 weeks prior to the screen visit.
20. Use of medications known to affect GI motility (e.g. Metoclopramide/Reglan).
21. Current use of weight loss medications such as Saxenda [liraglutide 3.0 mg], Xenical® [orlistat],
Acutrim® [phenylpropanolamine], Sanorex® [mazindol], Adipex® [phentermine], BELVIQ®
[lorcaserin], Qsymia® [phentermine/topiramate combination], Contrave® [naltrexone/bupropion],
or similar other weight loss medications including over-the-counter [OTC] medications [for
example, Allī®]) or have discontinued weight loss medications within 6 months.
22. Participation in any structured weight loss program or endoscopic weight loss intervention within
6 months of the screen visit.
23. Persistent anemia, defined as hemoglobin <10 g/dL.
24. Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of
hemoglobin abnormalities known to interfere with the measurement of HbA1c.
25. History of blood donation or transfusion within 3 months prior to the Screening Visit.
26. Unstable or paroxysmal cardiac arrhythmia.
27. Have any of the following cardiovascular conditions within 6 months prior to screen visit: acute
myocardial infarction, cerebrovascular accident (stroke), hospitalization due to congestive heart
failure.
28. History of valvular heart disease or chronic heart failure (NYHA III or IV).
29. Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 calculated by CKD-EPI Creatinine
Equation as determined by the central laboratory.
30. Known immunocompromised status, including but not limited to individuals who have undergone
organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have
clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or
whose immune status makes the participant a poor candidate for clinical trial participation in the
opinion of the investigator.
31. History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH
value outside the normal range at screening).
32. Presence of any implanted electronic devices that cannot be turned off during the procedure
33. Presence of duodenal or biliary stents.
34. Not a candidate for upper GI endoscopy or general anesthesia.
35. Active illicit substance abuse or alcoholism (>2 drinks/day regularly).
36. Active malignancy within the last 5 years (excluding non-melanoma skin cancers).
37. Women who are breastfeeding.
38. Participating in another ongoing clinical trial of an investigational drug or device.
39. Binge eating disorder, or any other mental or physical condition which, in the opinion of the study
investigator, makes the participant a poor candidate for clinical trial participation.
40. Critically ill or has a life expectancy <5 years.
41. Are investigator site personnel directly affiliated with this study and/or their immediate families.
Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally
adopted.
Additional exclusion criteria to be evaluated during the screening process:
42. HbA1c < 7.5% or > 10.5% at baseline visit.
43. Uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15 mmol/L) after an overnight fast
or >360 mg/dl (>20 mmol/l) in a randomly performed measurement that is confirmed by a second
measurement (not on the same day) between screening and baseline visit.
44. Any severe hypoglycemic event since the screening visit.
45. Poorly controlled hypertension, as evidenced by a mean of 3 separate blood pressure measurements
>180 mmHg (systolic) or >100 mmHg (diastolic).
46. Women of child-bearing potential with a positive urine pregnancy test at baseline visit.
47. LA Grade C or greater esophagitis on endoscopy.
48. Abnormalities of the GI tract preventing endoscopic access to the duodenum.
49. Anatomic abnormalities in the duodenum that would preclude the completion of the treatment
procedure, including tortuous anatomy.
50. Endoscopic observation of upper gastrointestinal abnormalities such as ulcers, duodenal polyps in
the area to be treated, varices, strictures, congenital or intestinal telangiectasia.
51. Any other anatomical or endoscopic abnormalities/characteristics that, in the opinion of the
investigator, would preclude safe use of the investigational device or procedure.
