Fractyl Health today announced that it published two-year durability data from its Revita-1 clinical study in Europe and South America.
Lexington, Massachusetts-based Fractyl’s trial included a two-year follow-up from 34 type 2 diabetes patients who received the company’s Revita duodenal mucosal resurfacing (DMR) procedure.
According to a news release, the study observed no long-term adverse events from Revita in patients with poorly controlled diabetes on oral glucose-lowering medications. HbA1c was observed to be statistically significantly reduced at all time points in the two-year cohort, as were broader measures of metabolic control, including reductions in weight and improvements in patient self-reported diabetes treatment satisfaction questionnaires (DTSQc).
There were no long-term treatment-related adverse events or device- or procedure-related serious adverse events, unanticipated device effects or hypoglycemic events observed between month six and month 24. One patient had mild constipation and another had mild vitamin B12 deficiency.
At 24 months following a single Revita procedure, there was an HbA1c reduction of 1% from baseline, a mean weight reduction of -3.1 kg from baseline and a mean increase of HDL of 6.4, all statistically significant. Diabetes treatment satisfaction was improved based on a statistically significant increase in DTSQc at 24 months, while mean levels of LDL, total cholesterol and triglyceride were not statistically significant from baseline to month 24.
“These results from our earlier REVITA-1 study give an encouraging picture of the potential long-term outcomes of Revita on multiple clinical and patient-relevant parameters, including glucose control, weight change, cardiovascular parameters and patient satisfaction,” Fractyl Health Co-Founder and CEO Dr. Harith Rajagopalan said in the release. “We are committed to rigorously evaluating the safety and effectiveness of Revita in patients with T2D across the spectrum of disease with our Revitalize T2D clinical development program.”