Prediabetes is defined by learned societies as a risk condition for developing type 2 diabetes. It corresponds to a moderate rise in fasting glycemia and/or a 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 lifetime.
Although type 2 diabetes is an irreversible condition in the large majority of cases, prediabetes itself can be reversed. It should be seen as a warning sign and an opportunity to take action.
The only treatment option available is adopting a healthier diet and lifestyle, as there is currently no drug or healthcare product that is specifically indicated for prediabetic patients.
Source : Tabak et al, The Lancet, 2012Learn more
million people worldwide, at least, were prediabetic in 2017, meaning they are at risk of developing type 2 diabetes.
Source: IDF, 2017
million people worldwide will have contracted type 2 diabetes by 2045, according to current forecasts (425 million people counted in 2017).
Source: IDF 2017
VALEDIA® is an innovation of worldwide importance designed for prediabetic patients.
Its purpose: to help these at-risk patients delay or even prevent the onset of type 2 diabetes.
It is the first in a new class of latest-generation, plant-based healthcare products developed by VALBIOTIS for the treatment of complex metabolic diseases.
TOTUM-63, the main active ingredient of VALEDIA®, is composed of a specific and patented combination of 5 plant extracts selected for their effects on metabolism. VALEDIA® acts on several targets of the pathophysiology of type 2 diabetes to reduce the disease clinical risk factors.
This “first-in-class” product is designed to change prediabetes management and to help maintaining the health of prediabetic subjects.
TOTUM-63 is the result of an intensive research and development program lasting several years, combining analytical chemistry and systematic screening on type 2 diabetes and prediabetes in vivo models.
During preclinical studies, TOTUM-63 has therefore proven to have major and significant effects on the main parameters of glucose metabolism:
These results were selected by the American Diabetes Association (ADA) for the scientific sessions of its annual Congress in June 2016.
The results of the Phase I/II clinical study led in 2017 were obtained on a population of healthy volunteers. These studies validated the safety and tolerance of VALEDIA® and provided proof of concept in terms of clinical efficacy, in line with the preclinical results:
These results were selected by the American Diabetes Association (ADA) in June 2017 for the scientific sessions of its annual Congress.
As with all VALBIOTIS products, TOTUM-63 has a pleiotropic mode of action. The biomolecules comprising TOTUM-63 act in synergy on several major targets involved in the physiopathology of type 2 diabetes:
These combined central and peripheral effects potentialize the impact of TOTUM-63 on carbohydrate metabolism and support the benefits measured in clinical studies.
VALEDIA® is currently in Phase II of clinical development. This development stage precedes the submission of an application for a health claim recognized by American, European and Canadian regulatory health authorities.
The four Phase II studies which are currently underway or pending must demonstrate the efficacy of VALEDIA® to reduce one or several risk factors of type 2 diabetes in the target population. These studies will include a total of almost 400 prediabetic patients.
VALEDIA® is protected by patents covering its active ingredient, TOTUM-63.
The protection strategy is global: patent applications have been filed for TOTUM-63 in 61 countries, including Canadian as well as European territories.
The patent was granted in France in 2014, then in the United States in 2018, with a very high level of protection. The American patent was granted by the USPTO* within an extremely short timeframe. In addition to the composition of TOTUM-63, the patent also protects its use for health applications specifically defined by VALBIOTIS, based on the product efficacy data.
*United States Patent and Trademark Office