Latest progress
Salubris, today announced that the Phase 3 clinical study of its innovative drug Fotagliptin benzoate for the treatment of diabetes has been unblinded and preliminary statistical analysis results showed good safety and tolerability.
Clinical data
Two randomized, double-blind, 24-week phase 3 clinical studies of Fotagliptin benzoate tablets as mono-therapy (12 mg/day) and in combination with metformin therapy in patients with type 2 diabetes verified the changes in HbA1c respectively.
The results showed that after 24 weeks of administration in patients with type 2 diabetes mellitus treated with mono-therapy or in combination with metformin, Fotagliptin benzoate tablets could significantly decrease HbA1c compared to placebo, and had a significant hypoglycemic effect.
The safety results of the two confirmatory phase 3 clinical studies suggest that the incidence of adverse events in the Fotagliptin benzoate group is similar to the placebo group or the positive control group; the incidence of hypoglycemia is similar to the placebo group or the positive control group, all of them were very low, and the Fotagliptin benzoate group did not increase the risk of hypoglycemia.
Fotagliptin benzoate is a dipeptidyl peptidase-4 (DPP-4) inhibitor with target indication of type 2 diabetes. Fotagliptin has the characteristics of rapid oral absorption, long half-life, long-lasting effect, etc. The launch of Fotagliptin will provide patients with more options for medication.
Relevant information
According to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China", the prevalsence of diabetes among adults in China has risen to 11.2%, of which more than 90% are type 2 diabetes.
Due to its unique mechanism of action and well-established efficacy, DPP-4 inhibitors have been increasingly used in clinical applications in recent years, and their status in domestic and foreign guidelines has become increasingly important. DPP-4 inhibitors currently listed in China include sitagliptin, vildagliptin, saxagliptin, alogliptin and linagliptin.
