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Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy (REVITALIZE 1)

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects with Type 2 Diabetes on Insulin Therapy

  • Clinical Trial Information

    Trial Contact: Garcia de Djuro, Ginette; Shepherd, Adriane R

    Trial Phone: 321.841.6649 ; 321 841-2285

  • IRB No: S23.123.06

    Protocol Abbrev: Revitalize-1

    Age Group: Adult

    Secondary Protocol No: C-00044

    Treatment: The DMR procedure consists of a highly controlled mucosal lift and ablation procedure of the post papillary duodenum using the Revita® System over the guided wire placed using a standard endoscope.

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT04419779

  • Objective

    To assess the efficacy of Revita® DMR for improving glycemic control in subjects with T2D compared to
    sham.

  • Key Eligibility

    Male and non-pregnant, non-lactating females
    2. Age between 21 and 70 years (both inclusive)
    3. Subjects with type 2 diabetes on stable doses of 20-100 units (both inclusive) of total daily insulin
    dose of basal insulin or basal insulin combined with short-acting insulin and up to 3 permitted noninsulin
    antidiabetic agents (ADAs). Permitted non-insulin ADAs include:
     Metformin,
     Glucagon-like peptide-1 receptor agonist (GLP-1 RA) including dual peptide agonists and
    related molecules (e.g., glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA),
     Dipeptidyl peptidase 4 inhibitor (DPP-4i),
     Thiazolidinediones (TZD),
     Sodium-glucose cotransporter 2 inhibitors (SGLT2i),
     Sulfonylureas (SU),
     Meglitinides
    4. Glycosylated hemoglobin A1c (HbA1c) of 7.5-10% (both inclusive) confirmed at the end of at least 3
    weeks of a stable run-in period
    5. Body mass index (BMI) >24 to ≤40 kg/m2
    6. Women of childbearing potential (WOCBP) should have a negative urine beta human chorionic
    gonadotropin (hCG) pregnancy test and must agree to use two of the established contraceptive
    methods throughout the study duration
    7. Able to sign an informed consent form and comply with study requirements