Poxel SA announced that Imeglimin, a novel compound in development for Type 2 diabetes, showed incremental efficacy as an add-on therapy to metformin, the reference first-line treatment, in patients inadequately controlled by metformin monotherapy. The study achieved its primary endpoint of superiority in HbA1c reduction versus placebo (p<0.001), and the decrease in FPG (Fasting Plasma Glucose) was also statistically significant (p<0.001). Reduction in HbA1c and FPG are two important measure of diabetes control.
Data from this Phase II trial assessing the clinical benefit of adding imeglimin to metformin demonstrate that in 12 weeks, patients in the imeglimin-metformin treatment group experience a -0.65 % reduction in HbA1c versus baseline. Moreover, the initial results indicated a trend towards reduced BMI (body mass index) and waist circumference, further indications of diabetes control. The overall safety and tolerability profile in the Imeglimin-metformin group was good.
Professor Valdis Pirags, Principal Investigator, commented, "I am pleased to see how positive these findings are. The results are exciting and we wait to further contribute to the development of this compound."
"The results from this add-on study are extremely encouraging, and I am confident that further development trials will reinforce the conclusion that Imeglimin is a safe and efficacious treatment option for diabetic people. There is still a need for new medications to control their disease," said Professor Harold Lebovitz, a distinguished member of Poxel's scientific advisory board... [PDF] Poxel's Press Release -
