Valbiotis (Euronext Paris:ALVAL), a French research & development company focused on scientific innovation to prevent and combat metabolic and cardiovascular diseases, announced on Thursday that it has recruited 600 volunteers for the international multicentre Phase II/III REVERSE-IT clinical study on TOTUM-63.
The study was co-designed by the Valbiotis and Nestlé Health Science medical and regulatory teams to demonstrate the efficacy of TOTUM-63, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage), as part of the global strategic partnership between the two companies.
The primary objective will be a reduction of fasting blood glucose levels after 24 weeks of TOTUM-63 supplementation compared to placebo. REVERSE-IT should confirm the positive results of the Phase II clinical study already obtained in a similar population with TOTUM-63.
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