VALBIOTIS announced positive results (topline data) for the Phase IIA study of VALEDIA (active substance: TOTUM-63), which evaluated this product's efficacy in a prediabetic population, compared to placebo.
In this population, VALEDIA significantly reduced fasting and post-prandial blood glucose levels, the two main risk factors for type 2 diabetes and the primary and secondary endpoints of the study, respectively. VALEDIA also significantly reduced body weight and waist circumference. Thanks to these results, VALEDIA is the first clinically validated product designed for prediabetic people, to reduce several risk factors for type 2 diabetes. These results enable the concomitant launch of the last two Phase IIB clinical studies (REVERSE-IT and PREVENT-IT), to obtain the first health claims for the risk reduction of type 2 diabetes in Europe and North America. This regulatory process does not require a Phase III study. Commercialization is planned for 2021, as previously announced.
Professor Jean-Marie BARD, Hospital Practitioner and Professor of Fundamental and Clinical Biochemistry at the University of Nantes, scientific expert for the study comments, “The reduction of fasting blood glucose and blood glucose 2 hours after a glucose intake is a new advance for prediabetics. These results show the impact of VALEDIA on metabolism, with even a decrease in body weight and waist circumference, usually hard to demonstrate in clinical studies. With such data, VALEDIA proves its efficacy to reduce type 2 diabetes risk factors.“
Murielle CAZAUBIEL, member of the board and Director of Development and Medical Affairs at VALBIOTIS, adds: “VALEDIA was designed to carry out multiple actions on several metabolic targets, thanks to an original plant-based composition. This innovation has had clinical success in people with prediabetes: we now know that VALEDIA acts on risk factors for type 2 diabetes. This study is a great success, and we’d like to express our thanks to all the volunteers who participated.”
Main results of the VALEDIA Phase IIA clinical study in prediabetic people
This multicenter study, conducted in Europe, evaluated TOTUM-63, the active ingredient of VALEDIA, in prediabetic people for 6 months. It was a randomized, double-blind, placebo-controlled study. Included subjects received a daily dose of 5 grams of VALEDIA while the control group received 5 grams of the placebo. Dietary habits and physical activity levels remained unchanged in both groups during the study. The inclusion criteria were strict to ensure the robustness of the study: the subjects had to have moderate hyperglycemia, hyperglycemia 2 hours after glucose dose (OGTT, Oral Glucose Tolerance Test), abdominal obesity and hypertriglyceridemia. With such characteristics, the included subjects were particularly at risk of fast and pejorative evolution. Analyses were conducted on 51 subjects, 13 in the placebo group and 38 in the VALEDIA group, according to the unbalanced study design.
Source: Company Press Release