Boehringer Ingelheim and Eli Lilly and Company recently submitted a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin to the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus (T2D) in adults.

Empagliflozin is a member of the SGLT2 inhibitor class of drugs being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.

"We are excited to have submitted an application for a potential new treatment option that may help patients better manage their type 2 diabetes mellitus," said Christophe Arbet-Engels, MD, PhD, MBA, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim. "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."

Empagliflozin is being investigated in adults with T2D in a phase III clinical trial programme that plans to enroll more than 14,500 patients. In total, this programme comprises 12 multinational clinical trials, including a large cardiovascular outcome trial. Boehringer Ingelheim and Lilly plan to present detailed data disclosures for many of these studies at scientific medical meetings and in publications in 2013 and 2014.

Type 2 Diabetes (T2D) is the most common type, accounting for an estimated 90 per cent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on three pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. The company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.