Mechanism of normal blood sugar absorption (left) versus insulin resistance in type 2 diabetes (right). Credit: Manu5.

French research and development company Valbiotis’ prediabetes product Valedia (TOTUM-63) significantly decreased blood glucose levels according to top-line results from a Phase IIa clinical trial.

TOTUM-63, the active substance of Valedia, combines five plant extracts that synergistically target physiopathological mechanisms of type 2 diabetes.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The drug is intended to minimise the risk of developing type 2 diabetes in the prediabetes population.

During the randomised, double-blind, placebo-controlled, multi-centre Phase IIa trial, a daily dose of 5g Valedia was compared to placebo over six months.

The study enrolled participants who had moderate hyperglycaemia, hyperglycaemia two hours following glucose dose, abdominal obesity, and hypertriglyceridemia.

Findings showed that the drug led to a reduction in both fasting and post-prandial glucose levels, thereby meeting the primary and secondary endpoints of the trial, respectively.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In addition, significant reductions were observed in body weight and waist circumference.

Commenting on the study results, Valbiotis CEO Sébastien Peltier said: “They demonstrate that TOTUM-63, the active substance of Valedia, reduces the two main risk factors for type 2 diabetes in people with prediabetes.

“This is a critical milestone for Valbiotis, we have now scientifically validated in humans the efficacy of our new plant-based approach to prevent metabolic diseases.”

This positive Phase IIa data facilitates the concomitant initiation of two Phase IIb trials, REVERSE-IT and PREVENT-IT. The new studies are intended to support the health claims in Europe and North America for type 2 diabetes risk reduction.

A previous Phase I/II trial in healthy volunteers demonstrated a favourable safety and tolerability profile for TOTUM-63. Valbiotis noted that the regulatory process for Valedia does not require a Phase III trial.

The company expects to commercially launch the prediabetes product in 2021.