Two phase III clinical trials found the investigational combination tablet of empagliflozin and linagliptin reduced blood glucose levels in adults with type 2 diabetes (T2D), Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company announced.

The findings were presented as late breaking abstracts at the American Diabetes Association 74th Scientific Sessions. The 24-week primary findings of these two 52-week trials compared the combination of empagliflozin and linagliptin with empagliflozin or linagliptin alone in patients with T2D and moderately elevated blood glucose levels consistent with what is often seen in clinical practice.

"We are encouraged by the reductions in blood glucose levels with the empagliflozin/linagliptin combination tablet and by the fact that more than half of the 494 adults with type 2 diabetes in these studies were able to achieve blood glucose goals below 7.0 per cent with the combination," said Christophe Arbet-Engels, vice president, metabolic clinical development and medical affairs, BIPI. "People with type 2 diabetes must often take more than one medication to adequately control their blood sugar levels. If approved, this combination tablet with two mechanisms of action that lower A1C through different pathways in a single pill could be an important treatment option for physicians and patients."

If approved, this investigational combination would bring together the distinct mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor for the first time in one tablet. SGLT2 inhibitors remove excess glucose through the urine by blocking blood glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor and is being studied for the reduction of blood glucose levels in adults with diabetes. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Empagliflozin is being studied in one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D.

Linagliptin, which is marketed as Tradjenta (linagliptin) tablets in the US, is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Tradjenta Tradjenta has not been studied in patients with a history of pancreatitis.

Tradjenta is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Tradjenta is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 85 to 95 per cent of all diabetes cases. Diabetes is a chronic condition 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 diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest US subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.