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Enrollment begins for trial of duodenal lining remodeling for type 2 diabetes therapy
Fractyl Laboratories announced that the first patient in Europe has been treated with a new therapeutic procedure aimed to benefit people with poorly managed type 2 diabetes, according to a company press release.
The procedure, called the Revita DMR, is a minimally invasive, outpatient therapy that rejuvenates the duodenum. The hour-long procedure involves using a heated balloon, placed in the intestine endoscopically, to condition the duodenal lining, according to the company website.
Recent studies have suggested that lifestyle and diet-induced changes to the duodenum can contribute to insulin resistance, according to the release.
“The clinical data we have gathered to-date suggests Revita DMR may address a significant unmet medical need, which is the underlying insulin resistance in patients with type 2 diabetes who are poorly controlled despite medications,” Harith Rajagopalan, MD, PhD, cofounder and CEO of Fractyl, said in the release. “We anticipate that the Revita-2 trial will further build the clinical support about the safety and efficacy of the Revita DMR procedure and inform the design of additional clinical trials.”
The trial is a randomized, sham-controlled, blinded study conducted across centers in Europe.