Boehringer Ingelheim's diabetes pipeline boosted by robust Phase III date for linagliptin

The US subsidiary of leading independent German drugmaker Boehringer Ingelheim as announced the conclusion of the linagliptin pivotal Phase III clinical trials, including more than 4,000 patients in 40 countries worldwide. Phase II data for linagliptin were presented earlier this year at the annual American Diabetes Association (ADA) Scientific Sessions. Full results from the Phase III trials will be reported at international scientific congresses in 2010 and beyond.

"Many diabetes patients do not achieve adequate blood sugar control with currently available medications, so there is a high degree of unmet medical need in this therapeutic area," said Thor Voigt, senior vice president, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals. "We hope that Boehringer Ingelheim will have the opportunity to introduce a new treatment option for patients living with type 2 diabetes that can help patients and physicians better reach treatment goals," he added.

Linagliptin belongs to the dipeptidyl peptidase 4 (DPP-4) inhibitor class, a newer class of oral hypoglycemics that target the incretin hormones GLP-1 and GIP, which are believed to be involved with regulating blood sugar.(1)

There are approximately 23.6 million Americans and 246 million people worldwide with diabetes. Type 2 diabetes is the most common type of the disease, accounting for more than 90% of all cases in the developed world.

Boehringer Ingelheim is also investigating sodium-dependent glucose co-transporter-2 inhibitors (SGLT-2 inhibitors), which are a new, emerging class of antidiabetic compounds that block tubular reabsorption of glucose in the kidney. Phase IIb clinical trials for this innovative approach to diabetes treatment are underway. There are currently no SGLT-2 inhibitors approved by the US Food and Drug Administration, the company notes.