La Rochelle -
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
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
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
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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