Boehringer Ingelheim and Eli Lilly and Company have announced the submission of new drug application (NDA) to FDA for an investigational type 2 diabetes mellitus (T2D) treatment, empagliflozin.
Empagliflozin belongs to sodium glucose co-transporter-2 (SGLT2) inhibitor class of drugs, which blocks glucose re-absorption in the kidney and eliminates excess glucose through the urine.
Boehringer Ingelheim metabolic-clinical development and medical affairs vice president Christophe Arbet-Engels said, "Type 2 diabetes mellitus is a critical health issue facing the world today, and through the Boehringer Ingelheim and Lilly Diabetes Alliance, we are committed to developing new treatments to address patients with this disease."
A Phase III trial program comprising 12 multinational clinical trials will assess empagliflozin in over 14,500 adult patients with T2D.
The companies expect to report results of the studies in 2013 and 2014.
