La Rochelle - 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.

With the data announced today, the REVERSE-IT study is a breakthrough for the prevention of type 2 diabetes: TOTUM 63, a non-drug, plant-based active substance reduces glycated hemoglobin and fasting blood glucose with results at least comparable to some drugs, such as metformin, in a similar population. We also demonstrated a 40% reduction in the number of new diagnoses of type 2 diabetes among prediabetics. The objective we set ourselves with our partner Nestle Health Science has been achieved: to demonstrate with unequivocal clinical evidence that we can act successfully at a very early stage, for the benefit of patients. I would like to underline the great joint success of our partnership with Nestle Health Science, with whom we have an exclusive and global licence agreement on TOTUM 63. For Valbiotis, it is a tremendous achievement, and one that will lead to further successes in the future. But above all, it is a real breakthrough for the patients and people at risk who will benefit from this global innovation, explains Sebastien PELTIER, co-founder and Chairman of the Valbiotis Executive Committee.

Diabetes: a global public health challenge

Around 537 million adults (aged 20-79) live with diabetes worldwide, 90% of whom have type 2 diabetes, according to the International Diabetes Federation1. In addition to this growing number, there are almost 900 million people affected by prediabetes, including 128 million in the United States and the five main European countries2.

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 world s leading 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

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