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First patients enrolled in trial of Revita duodenal mucosal resurfacing system for type 2 diabetes
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The first patients have been enrolled in the Revita-1 clinical trial evaluating the safety and performance of the Revita Duodenal Mucosal Resurfacing System at ten centers across Europe and South America, the manufacturer announced.
The Revita Duodenal Mucosal Resurfacing (DMR) System (Fractyl Laboratories) is a first-of-its-kind minimally invasive, device-based, implant-free procedure intended to directly treat the intestinal hormonal impairment that contributes to insulin resistance in patients with uncontrolled type 2 diabetes, according to a press release.
“The Revita-1 study will expand our understanding of the safety and efficacy of the Revita DMR procedure in patients with type 2 diabetes,” Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl, said in the release. “It will also guide our plans for multi-arm pivotal trials, along with data from our earlier, proof-of-concept human studies that we plan to publish this year.”
According to the release, the first phase of the study will enroll 50 patients in total (ten have been treated so far), and the primary efficacy endpoint is change in HbA1c. The second phase will be a double-blind, sham-controlled trial involving up to 240 patients, which will begin in 2016, the release said.
“My center has now treated four patients in the Revita-1 trial, and two patients have crossed the 1-month threshold and appear to be well satisfied with this minimally invasive procedure,” Geltrude Mingrone, MD, PhD, said in the release. “We have known for some time that bariatric surgeries can improve glycemic control independent of weight loss; it will be interesting to see if Revita can offer a safe, less invasive option with similar metabolic benefits.”
This clinical program is designed to show the Revita DMR system can significantly improve glucose control in type 2 diabetes patients, which may reduce the need for additional medications, the release said.
Disclosure: Rajagopalan is an employee of Fractyl. Healio Gastroenterology was unable to confirm Mingrone’s relevant financial disclosures at the time of publication.