Diabetes innovative oral therapy imeglimin successfully in a Phase 3 clinical trial

recently, Poxel Bio
Medicines(http://http://
and partner Sumitomo DayouPharmaceutical son
(http://announced the success of its innovative diabetes innovation oral therapy, imeglimin, in a phase 3 clinicaltrial(http://imegliminimeglimin is a new type of oraldrug(http://that targets mitocho
ndrial bioenergetics of mitocho Poxel scientists believe mitochondrial dysfunction is one of the causes of diabetes, and enhanced bioenergy is expected to reverse the potential cause of the disease 　　By the mechanism, the drug can act on the liver, muscles, and the three major organs of the pancreas, promising to promote insulin secretion, increase insulin sensitivity, and inhibit sugar isogenesis Taken together, this is expected to have a clinical effect of lowering blood sugar In addition, Poxel's public information indicates that imeglimin has the potential to provide protective effects for cardiovascular and islet beta cells 　　In Japan, researchers conducted a large-scale Phase 3 clinical project to assess the efficacy and safety of imeglimin in the treatment of type 2 diabetes The project recruited more than 1,100 patients who were assigned to three different key clinical trials Announced today is the result of the first Phase 3 clinical trial, TIMES 1 as a double-blind, randomized, placebo-controlled clinical trial, TIME 1 used HbA1c (glycated hemoglobin A1c) as the main clinical endpoint, and secondary clinical endpoints included indicators such as fasting blood sugar 　　The study found that after receiving imeglimin's single-drug treatment, the average HbA1c level of patients decreased by 0.87% compared to the baseline and was statistically significant (p 0.0001) On the secondary endpoint "fasting blood sugar", the treatment group's data decreased by 19 mg (-19 mg/dL) per deciliter, also statistically significant (p0.0001) Some analytical (http:// indicated that another diabetes drug on the market in Japan, with a decrease of 0.8% and a 17 mg/dL per decire, respectively Similar data are expected to support the approval of imeglimin's application in Japan