– Last stage of clinical development, in partnership with Nestlé Health Science
Today, TOTUM•63 is in Phase II/III of its clinical development, the last stage 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.
The study enrolls 600 patients with prediabetes or early-stage untreated type 2 diabetes. Its primary endpoint is a reduction of fasting blood glucose.
The REVERSE-IT study targets two strategic objectives:
• Confirm Phase II’s positive results on fasting blood sugar levels, a well-established risk factor for developing type 2 diabetes;
• Extend the evaluation of TOTUM•63 to patients with early-stage untreated type 2 diabetes to broaden the final target population.
In addition, a mode of action clinical study in humans will be implemented by INAF, Quebec City (Canada). It will provide additional data to strengthen the scientific communication and support the commercialization of TOTUM•63.