Interim data from the investigator-initiated INSPIRE clinical trial, in collaboration with Fractyl, show that a same-day therapeutic procedure called Revita DMR can help eliminate the need for daily insulin injections in patients with type 2 diabetes.
The results of the trial at the American Diabetes Association’s 79th Scientific Session in San Francisco. The Revita DMR (duodenal mucosal resurfacing) technique uses water and heat to resurface the mucous membrane in the small intestine, encouraging a new membrane to develop. The goal of the process is to reset the organ’s hormone production, which, when faulty, is a root cause of insulin resistance, leading to diabetes and other metabolic diseases.
From Fractyl’s press release:
The INSPIRE study completed enrollment at 16 patients, out of which 13 patients have reached the six-month follow-up, and 11 of 13 (85%) are insulin-free. The remaining three patients are still in the trial but have not reached their six-month follow-up for this interim analysis. In addition, patients have seen nearly 45 percent reduction in liver fat on MRI-PDFF (from a baseline of 8.5 percent absolute liver fat), along with significant improvements in blood pressure and weight.
“Other than extreme interventions, this is the first same-day treatment that has the potential to free patients with advanced type 2 diabetes from daily insulin injections,” said Jacques Bergman, M.D., Ph.D., a professor of gastroenterology at Amsterdam UMC and principal investigator of the INSPIRE study. “Our results suggest we can use a straightforward and safe outpatient procedure to eliminate the need for daily insulin, which could have a meaningful positive impact on the hundreds of millions of people across the world suffering from type 2 diabetes.”
- FierceBiotech: ADA: Fractyl’s intestine-resurfacing procedure shows people with Type 2 diabetes going insulin-free for 6 months
- The Guardian: ‘Spectacular’ diabetes treatment could end daily insulin injections
- Medical Device and Diagnostic Industry (MD+DI): Could Revita DMR be an Alternative to Insulin Use?