TOTUM•63: for the management of prediabetes and early stage, untreated, type 2 diabetes

TOTUM•63 is a unique and patented combination of 5 plant extracts, designed to target a number of pathophysiological mechanisms of type 2 diabetes.
TOTUM•63 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.

17 communications at international scientific congresses since 2016, including 14 selections by the three main global diabetes congresses: American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), and the International Diabetes Federation (IDF).
7 scientific papers published by international journals since 2021.

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Prediabetes: an unmet global need

Prediabetes is defined by learned societies as a risk condition for developing type 2 diabetes¹. It involves a moderate rise in fasting blood glucose and/or glucose intolerance and/or a moderate increase in glycated hemoglobin levels (HbA1c). Without effective treatment, 70% to 90% of prediabetic patients will develop type 2 diabetes during their lifetime². Although type 2 diabetes is an irreversible condition in the large majority of cases, prediabetes can, for its part, be reversed: it is a warning sign and an opportunity to take action. The only treatment option available is a healthier diet and lifestyle, as no drug or healthcare product specifically indicated for prediabetic patients exists today.

Sources:
¹Standards of care in Diabetes, ADA 2017;
²Tabak AJ. et al., Lancet, 2012;
³Nathan DM. et al., Diabetes Care, 2007;
4Knowler WC et al., N Engl J Med, 2002.

Key figures on prediabetes

900 million people worldwide are prediabetic today and at risk of developing type 2 diabetes.

Source: AEC Partners 2019.

1.3 billion people worldwide might have diabetes by 2050, according to current forecasts (537 million estimated in 2019).

Source: Global Burden Disease, The Lancet, 2023 ; IDF 2019.

TOTUM•63, a multi-target mode of action

A clinical study on the mode of action was conducted at the Institute of Nutrition and Functional Foods (INAF) of Laval University in collaboration with the Quebec Heart and Lung Institute (IUCPQ).
The study confirms TOTUM•63’s efficacy results, in particular the lasting reduction in glycated hemoglobin, one of the main markers of prediabetes and type 2 diabetes.
It shows three main effects of TOTUM•63 on the energy metabolism of subjects at risk:

Reduced inflammation (blood hsCRP and fibrinogen), involved in the development of insulin resistance;
Modulation of certain key gastrointestinal hormones (GIP and PYY), involved in the regulation of metabolism and satiety;
Enhanced metabolic response after meals, with a lesser increase in blood glucose and lipid levels leading to a decrease in insulin secretion.

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Clinical development of TOTUM•63

TOTUM•63 is a unique patented combination of five plant extracts that target the key pathophysiological mechanisms of type 2 diabetes. The efficacy of TOTUM•63 is the subject of the first health claim related to the reduction of the risk of type 2 diabetes filed in Europe, North America and other key markets.

– The success of the Phase II/III REVERSE-IT clinical study

The Phase II/III REVERSE-IT study is the last stage in the clinical development of TOTUM•63, before the submission of an application for a health claim recognized by the American, European and Canadian regulatory authorities. This international randomized, placebo-controlled, double-blind study called “REVERSE-IT” was launched in mid-2020. It enrolled 636 patients with prediabetes or early-stage untreated type 2 diabetes, in 52 centers from 7 countries.

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.

Detailed results 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.

– Safety and tolerance on TOTUM•63

The safety and high tolerance of TOTUM•63 were demonstrated in all clinical studies, Phase I/II, Phase II and Phase II/III REVERSE-IT.

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Intellectual property of TOTUM•63

Valbiotis has adopted a global strategy to protect its intellectual property.
TOTUM•63 benefits from intellectual property validated by patents in the world’s major markets including Europe (covering 39 countries), the United States, Canada, China, Japan, Australia, Mexico, etc.