Valbiotis SA announced 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.

TOTUM?63 responds to an essential need that has been neglected until now: early intervention in the metabolic impairments associated with type 2 diabetes, particularly in prediabetes. No other non-drug health product currently boasts a level of efficacy as clearly demonstrated as TOTUM?63. With the completion of its clinical development, TOTUM?63 opens up new prospects both for people facing the risks associated with diabetes and for doctors, who currently lack reliable solutions dedicated to prevention.

TOTUM?63: a worldwide innovation in health nutrition for prediabetic and type 2 diabetic patients: In the field of prediabetes and untreated type 2 diabetes, the REVERSE-IT study surpasses studies carried out to date using nutritional approaches, both in terms of its scale (636 volunteers) and the number of centers involved internationally (52 centers in 7 countries). In terms of methodology, the REVERSE-IT study complies with the recommendations of international learned societies, in particular those of the American Diabetes Association, the learned society for diabetes. Design of the Phase II/III REVERSE-IT study: REVERSE-IT studied the overall efficacy of TOTUM?63, a plant-based active substance, on key markers of glucose metabolism in a randomized, placebo-controlled trial.

It included 636 people: 501 prediabetics and 135 early-stage, untreated type 2 diabetics. Patients were divided into three arms, each with over 200 participants: A blind arm supplemented with TOTUM?63 (5 g/day) in 3 intakes per day, An open arm supplemented with TOTUM?63 (5 g/day) in 2 intakes per day, A placebo arm. The duration of supplementation was 6 months.

All participants received identical dietary and physical activity advice, with no significant difference between groups at the end of the study. Widely demonstrated efficacy in prediabetic and early-stage untreated type 2 diabetic patients: The primary endpoint of the study, a reduction in fasting blood glucose levels after 6 months of TOTUM?63 supplementation at 3 intakes per day versus placebo, was achieved (-5.8 mg/dl, p=0.015), as it was with TOTUM?63 at 2 intakes per day (-8.1 mg/dl, p<0.001). No statistically significant differences were observed between the 3 and 2 intakes per day groups.

The main markers of glucose metabolism - 2-hour blood glucose (-21.9 mg/dl), glycated hemoglobin (HbA1c, -0.18%) and insulin resistance (HOMA-IR, -1.04 points) - were also significantly reduced by TOTUM?63 taken twice daily versus placebo. These results demonstrate the overall efficacy of TOTUM?63 on key markers of glucose metabolism in both prediabetic and early-stage untreated type 2 diabetic patients. Moreover, in prediabetic patients, TOTUM?63 reduced disease progression and the number of new cases of type 2 diabetes by 40% after 6 months, compared with placebo, with two intakes per day.

The results also showed a benefit on low-grade inflammation, with a 13% reduction in the number of volunteers above the inflammation threshold (hsCRP). These chronic low-grade inflammatory processes are directly involved in the pathogenesis of type 2 diabetes. With efficacy values comparable to those of certain anti-diabetic drugs such as metformin, in a similar population, particularly in terms of fasting blood glucose and glycated hemoglobin3, TOTUM?63 can easily find its place in strategies for both the prevention in prediabetics and early stages of type 2 diabetes.