Fractyl Laboratories announced today that it enrolled the first patient in the trial for its Revita DMR Type 2 diabetes treatment.
The Revita-T2Di trial will evaluate a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control. The company will seek to use the trial as the basis of a marketing application to the FDA, according to a news release.
Revita DMR is an outpatient endoscopic procedure designed to resurface the upper intestine lining (duodenal mucosa) in metabolic disease. It has CE mark approval in Europe but is so far only qualified in the U.S. under FDA investigational device exemption.
The trial is a prospective, randomized, double-blind, sham-controlled study expected to enroll more than 300 patients at up to 35 sites in the U.S. and Europe to evaluate the efficacy of Revita DMR. The primary endpoint is the percentage of patients who are able to achieve target glycemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks.
Lexington, Mass.-based Fractyl has begun enrolling patients at the first clinical site, Indiana University Health. Additional sites will be announced in the coming months.
“We are pleased to initiate this global pivotal study of Revita DMR, a procedural therapy which we believe could significantly impact the lives of people living with type 2 diabetes whose blood sugar levels remain uncontrolled despite being on insulin therapy,” Fractyl co-founder & CEO Dr. Harith Rajagopalan said in the release. “In collaboration with clinical sites in the United States and Europe, we look forward to evaluating Revita DMR in a segment of the type 2 diabetes population who are most at risk for hypoglycemia, weight gain and other significant complications of insulin therapy.”