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)

Endogenex, Inc.44 sites in 2 countries264 target enrollmentMay 1, 2024

ConditionsType 2 Diabetes Mellitus Type2diabetes Diabetes Mellitus, Type 2 Diabetes Type 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Endogenex, Inc.
Enrollment: 264
Locations: 44
Primary Endpoint: HbA1c
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.

Detailed Description

This is a prospective, multi-center, randomized, double-blind, sham-controlled, adaptive study enrolling individuals with type 2 diabetes inadequately controlled on non-insulin glucose-lowering medications. Participants will be randomized to receive the ReCET therapy or sham procedure consisting of device insertion without treatment. Participants will be followed for 6 months for the primary endpoint and 12 months in total. After 12 months, participants randomized to the sham arm may cross-over to receive the ReCET procedure.

Registry

clinicaltrials.gov

Start Date

May 1, 2024

End Date

October 1, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Endogenex, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•22- 70 years of age, inclusive.
•T2D diagnosis for at least 6 months.
•HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.
•BMI 27-40 kg/m2, inclusive.
•On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1 or GLP-1/GIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.
•Individualized metabolic surgery (IMS) score ≤
•Weight stability (≤5% weight change) for at least 12 weeks prior to the screening visit.
•Agree not to donate blood during participation in the study.
•Able to comply with study requirements and understand and sign the Informed Consent Form.
•Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.

Exclusion Criteria

•Diagnosed with type 1 diabetes.
•History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
•Fasting serum C-peptide \<1 ng/mL (333pmol/l).
•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.
•Hypoglycemic unawareness.
•History of ≥1 severe hypoglycemia episode in past 6 months
•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.
•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, or as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test.
•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.
•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.