Duodenal mucosal resurfacing reduces HbA1c, body weight at 24 weeks in type 2 diabetes
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A first-in-class duodenal mucosal resurfacing therapy is associated with reductions in HbA1c and body weight at 24 weeks among a cohort of insulin-treated adults with type 2 diabetes, according to a company press release.
As Healio previously reported, the FDA granted a breakthrough device designation for duodenal mucosal resurfacing (Revita DMR, Fractyl Laboratories) in May 2021 for adults with type 2 diabetes who have inadequate glycemic control with long-acting insulin. The therapy consists of an outpatient endoscopic procedure in which a hot liquid is used to remodel the duodenal lining in order to edit abnormal intestinal nutrient sensing and signaling mechanisms.
In 6-month interim data from the REVITA-T2Di open-label cohort, mean HbA1c decreased from 8.5% at baseline to 7.5% at 24 weeks in a small cohort of eight adults who underwent the procedure, according to the release. Three participants no longer needed insulin therapy at 24 weeks. Additionally, the mean total body weight among the cohort decreased by 6.8%.
“We are encouraged by the 24-week data from this clinical experience with Revita in showing improvements in glucose control and weight with a significant reduction in insulin requirement,” Geltrude Mingrone, MD, PhD, professor of internal medicine at the Catholic University in Rome and professor of diabetes and nutrition at King’s College, London, said in the release. “Aside from bariatric surgery, physicians do not have accessible tools today to improve glucose control and reduce drug burden. What is exciting about this cohort is that it shows Revita may offer the potential to not only improve glucose control for patients with advanced disease, but also potentially help to reduce or eliminate their need for insulin.”
The REVITA-T2Di cohort included nine adults with type 2 diabetes at baseline and an HbA1c ranging from 7.5% to 9.5%. Participants started the study with an 8-week washout period in which diabetes drugs other than metformin or basal insulin were stopped. Following a 4-week run-in period, participants underwent the procedure at four treatment centers. The average procedure duration was less than 1 hour and there have been no adverse events reported. One of the nine adults discontinued participation in the study for reasons unrelated to the trial.
In the press release, Fractyl Health announced it planned to give regular updates on the cohort included a 48-week durability data update, later in 2023.
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