The study has met its primary endpoint of superiority in HbA1c reduction versus placebo and the decrease in FPG was also statistically significant.
The 12 week phase II trial with 150 patients demonstrated that the imeglimin-sitagliptin treatment group experienced 0.73% reduction in HbA1c versus placebo.
Poxel scientific advisory board member professor Harold Lebovitz said, "They do confirm the attractiveness of Imeglimin for both regulators and future prescribers: the molecule is unique and demonstrates its great efficacy potential in monotherapy as in combination with the two most important molecules on the treatment armamentarium today, metformin and sitagliptin."
Poxel CEO Thomas Kuhn said the second clinical trial demonstrates Imeglimin`s potential to complement efficacy of drugs.
”Within the type 2 diabetes landscape, Imeglimin is ahead in a race where new entrants have yet to prove their efficacy, their combinability and their safety."