Trial Details

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 With Inadequate Glycemic Control

NCT04419779

SUSPENDED

DESCRIPTION

The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.

CONDITIONS

ELIGIBILITY CRITERIA

• Inclusion Criteria
• Subjects must meet all of the following criteria for inclusion in the study: 1. Males and non-pregnant non-lactating females 2. Age between 21 and 70 years (both inclusive) 3. Subjects on at least one glucose lowering agent (GLA) with no changes in GLA medications or dosing for at least 12 weeks prior to the screening visit Permitted GLAs include:
• Metformin,
• GLP-1 RA including dual peptide agonists and related molecules (e.g., GLP-1/GIP RA),
• DPP-4i,
• TZDs,
• SGLT2is,
• SUs,
• Meglitinides,
• Insulin (basal or basal combined with short-acting), up to a total of 100 units daily 4. HbA1c of 7.5%-10% (both inclusive) 5. BMI \>24 to ≤40 kg/m2 6. WOCBP should have a negative urine beta hCG pregnancy test and must agree to use two of the established contraceptive methods throughout the study duration 7. Able to sign an ICF and comply with study requirements
• Exclusion Criteria
• Subjects who meet any of the following