735-P: Baseline Characteristics in the REVERSE-IT Study, a 24-Week, 600-Person Randomized Placebo-Controlled Study of the Metabolic Effects of the Combination of Five Plant Extracts TOTUM-63 (T63)

Abstract

The role of natural based products to support glucose control in people with prediabetes or early type 2 diabetes (T2D) (i.e. dysglycemia) is debated. T63 is a polyphenol-rich substance composed by artichoke, chrysanthellum, olive leaf, bilberry, and black pepper extracts, and studied in REVERSE-IT (NCT04423302), an ongoing 24 weeks, multi-center, multi-country clinical trial involving people with dysglycemia. It tests the hypothesis that 5 g T63 vs placebo (PBO) leads to significant reduction in fasting plasma glucose, while secondary outcomes include effects on lipids, blood pressure (BP), weight and waist circumference. The confirmatory primary analysis will compare T63 vs PBO when provided TID (double-blinded) and is powered based on minimum 174 completers in each arm. Effects of T63 BID vs PBO will be analyzed open label. A total of n=627 were recruited over 2 years from 61 sites across 7 European countries. Mean age is 57 years, BMI 32.2 kg/m2, and HbA1c 6.1% (table 1). The majority have prediabetes (78.3%), with a better glycemic profile and BP compared to those with T2D (21.7%). REVERSE-IT has enrolled an appropriate population to help inform clinical decision making on the use of plant-extract based T63 to support glucose homeostasis in people with dysglycemia. Readout is expected in the second half of 2023. Disclosure Y.F.Otero: Employee; Valbiotis. T.Maugard: None. M.Cazaubiel: Board Member; Valbiotis. B.Pereira: None. B.Guigas: Advisory Panel; Valbiotis, Research Support; Valbiotis. S.Hadjadj: Consultant; Bayer Inc., Novo Nordisk, Valbiotis, Research Support; AstraZeneca, Novartis, Speaker's Bureau; Abbott Diagnostics, Boehringer-Ingelheim. S.Peltier: Board Member; Valbiotis. A.Marette: Advisory Panel; Valbiotis, Amancia, Plexus, Acasti. J.Bard: Consultant; Valbiotis, Biofortis France, Stock/Shareholder; Valbiotis. P.Sirvent: Board Member; Valbiotis. O.Johansen: Employee; Nestlé Health Science. V.Chavanelle: Employee; Valbiotis. M.Bargetto: Employee; Valbiotis. V.Sapone: None. A.Bouchard-mercier: Employee; Valbiotis. F.Le joubioux: Employee; Valbiotis. N.Boisseau: None.