Lexicon Pharmaceuticals Inc.'s second phase 3 trial of sotagliflozin in adults with type 1 diabetes met its primary endpoint with a statistically significant reduction in A1C levels compared to placebo.
Sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter type 1 and 2.
The A1C test measures the glucose in blood by assessing the amount of glycated hemoglobin. Results from the study showed that patients treated with the drug had mean A1C reductions from baseline of 0.39% on a 200-milligram once-daily dose and 0.37% on the 400 mg once-daily dose, compared with a reduction of 0.03% on placebo, after 24 weeks of treatment.
The 782 adult patients in Europe and Israel had an A1C level entering the study between 7.0% and 11.0%.
The results confirm the results announced earlier in 2016 from the first phase 3 study of sotagliflozin, President and CEO Lonnel Coats said in a statement.
Lexicon is conducting a third phase 3 trial in type 1 diabetes patients, which is studying about 1,400 patients treated with sotagliflozin 400 mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization.
Sanofi is responsible for development and commercialization of sotagliflozin for the treatment of type 2 diabetes in the licensed territory and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. Lexicon is responsible for development activities relating to type 1 diabetes and retains an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of the drug for the treatment of type 1 diabetes in the U.S.