The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal
mucosal resurfacing (DMR) Procedure using the Revita System compared to a sham procedure for
the treatment of uncontrolled type 2 diabetes.
Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham
treatment arm will cross over to receive the DMR treatment at 24 weeks with background
medications held constant from 24-48 weeks of follow up.