121-LB: Durable Glycemic Improvements after Duodenal Mucosal Resurfacing (DMR) in Patients with Type 2 Diabetes (T2D): 48-Week Results from the REVITA-2 European Cohort

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Background: DMR is a minimally invasive, endoscopic procedure designed to treat insulin resistance-related metabolic diseases via hydrothermal rejuvenation of duodenal mucosa leading to improvement in insulin sensitivity. Primary (24 week) results from REVITA-2, the first randomized, sham-controlled, double-blind, prospective, multicenter study, demonstrated that a single DMR procedure safely elicits significant improvements in glycemic and hepatic parameters in sub-optimally controlled T2D. Here we report on durability of glycemic results through 48 weeks posttreatment in REVITA-2 patients at 9 European study centers. Method: Eligible patients were aged 28-75 years, taking ≥ 1 OAD, had HbA1c levels 7.5%-10.0%, and BMI of 24-40 kg/m2. The modified intent-to-treat (mITT) population included randomized patients in whom a procedure was attempted. Patients lost to follow up were excluded, and data obtained post-rescue medication were set to missing. Significance (0.05 level) was determined using a 2-sided Wilcoxon signed-rank test. Results: Thirty-one of 39 patients randomized to DMR (mITT) were followed to 48 weeks. Median change from baseline HbA1c was -0.6% at 24 weeks (n = 38, p = 0.003) and -0.7% at 48 weeks (n = 27, p < 0.001). Sixty-eight percent of patients achieved a reduction in HbA1c from baseline at 24 weeks (median HbA1c change: -1.1%) and were defined as responders. Most responders (84%) maintained a durable response through 48 weeks (median HbA1c change: -1.0%) without an increase in antidiabetic medication. Median weight change was -2.4 kg at 24 weeks (n = 38, p < 0.001) and -2.1 kg at 48 weeks (n = 28, p = 0.003). Conclusion: A single DMR procedure safely elicits durable, clinically significant glycemic improvements through 48 weeks posttreatment in suboptimally controlled T2D; most patients who respond at 24 weeks maintain the beneficial effects at 48 weeks without needing additional medication. Disclosure G. Mingrone: Consultant; Self; Fractyl Laboratories, Inc., Johnson & Johnson, Novo Nordisk A/S. D. Hopkins: Advisory Panel; Self; Fractyl Laboratories, Inc., Roche Diabetes Care. Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk A/S, Sanofi, Sunovion Pharmaceuticals Inc. G. Aithal: None. G. Costamagna: Advisory Panel; Self; Cook Medical, Ethicon, Inc., Olympus. Research Support; Self; Apollo EndoSurgery, Boston Scientific. L. Crenier: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk Inc., Sanofi. J.M. Deviere: Research Support; Self; Fractyl Laboratories, Inc. R. Drummond: None. R. Haidry: None. I.R. I: None. A. Lania: Research Support; Self; Ipsen Biopharmaceuticals, Pfizer Inc. C. Magee: None. M. Nieuwdorp: Board Member; Self; Caelus Health, Kaleido Biosciences. V. Bhambhani: None. J. Huang: Employee; Self; Fractyl Laboratories, Inc. K. White: Employee; Self; Fractyl Laboratories, Inc. Stock/Shareholder; Self; Johnson & Johnson. J. Lopez-Talavera: Employee; Self; Fractyl Laboratories, Inc. H. Rajagopalan: Employee; Self; Fractyl Laboratories, Inc. J.J. Bergman: Research Support; Self; Fractyl Laboratories, Inc. Other Relationship; Self; Fractyl Laboratories, Inc.

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