Fractyl Laboratories announced publication of data from its first-in-human study of Revita DMR (duodenal mucosal resurfacing) for the treatment of patients with type 2 diabetes. Study findings and analysis, entitled “Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis from the First-in-Human Proof-of-Concept Study,” were published in the current issue of Diabetes Care.
The study included 39 patients with type 2 diabetes poorly controlled on one or more oral antidiabetic agents (screening HbA1c: 9.5%). Results showed that Revita DMR significantly improved glycemic control in these patients, with a predominant effect of lowering fasting hyperglycemia, suggestive of a potential insulin-sensitizing mechanism. The study found that treatment with Revita DMR was well-tolerated, with minimal gastrointestinal symptoms post procedure.
Revita DMR is a same-day, minimally invasive, trans-oral procedure that targets the duodenum, a site that plays an important role in regulating insulin sensitivity and metabolic homeostasis, to potentially address insulin resistance at its source. It utilizes proprietary balloon catheters to rejuvenate the surface of the duodenum and potentially alter gut signaling through a combination of circumferential mucosal lift and hydrothermal ablation.
Clinical trials for the Revita DMR procedure and device are currently ongoing. An international, multicenter trial in 50 patients with type 2 diabetes is currently underway.
For more information visit Fractyl.com.