VALBIOTIS SA: Valbiotis Presents the Full Results of the Phase II/III REVERSE-IT Study: Impressive Efficacy of TOTUM•63 Against Prediabetes and the Early Stages of Type 2 Diabetes, a First for a Non-drug Active Substance

• The REVERSE-IT study has met its primary endpoint: TOTUM•63 reduced fasting blood glucose at 6 months versus placebo, on both a 3-intake/day and a 2-intake/day regimen, the optimal regimen for marketing and real-life patient compliance ( press release, May 22 ).
• Detailed results today demonstrate TOTUM•63's impressive efficacy on glucose metabolism, including plasma glycated hemoglobin (HbA1c), a biomarker established for microvascular risk, used for monitoring type 2 diabetes, with results comparable to some anti-diabetic drugs in a similar population.
• Among the main results, TOTUM•63 supplementation at 5 g/day, in 2 intakes, after 6 months:
• significantly reduces fasting blood glucose (-8.1 mg/dl), 2-hour blood glucose (-21.9 mg/dl), glycated hemoglobin (-0.18%) and the HOMA-IR insulin resistance score (-1.04 pts), the main markers assessed in clinical practice, compared with placebo;
• significantly reduces progression towards type 2 diabetes, with a 40% relative reduction in new cases of type 2 diabetes at the end of the study versus placebo;
• significantly reduces low-grade inflammation (-13% of patients above the threshold) involved in the pathogenesis of type 2 diabetes ;
• demonstrates its efficacy on fasting blood glucose and glycated hemoglobin in early-stage untreated type 2 diabetics.
• The study confirms TOTUM•63's excellent safety profile, with no risk of hypoglycemia, very good tolerability, notably digestive, and a compliance exceeding 97%.
• With such data, the REVERSE-IT study positions TOTUM•63 as an unparalleled non-drug innovation in the fight against the type 2 diabetes epidemic, benefiting the millions of people today facing the risks associated with this disabling chronic disease.

LA ROCHELLE, FRANCE / ACCESSWIRE / September 11, 2023 / Valbiotis (FR0013254851 - ALVAL, PEA/SME eligible), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the results of the international Phase II/III REVERSE-IT study, demonstrating TOTUM•63's impressive efficacy on key markers of glucose metabolism, with efficacy results comparable to those of some leading anti-diabetic drugs, in a similar population. With REVERSE-IT, TOTUM•63 now has unrivaled proof of efficacy for a non-drug health product against prediabetes and the untreated early stages of type 2 diabetes. This new, natural, clinically proven product will benefit people affected by the risks associated with diabetes and support them in the fight against the progression of this disease, alongside their physician.