Boehringer Ingelheim Pharmaceuticals, Inc, a Ridgefield, Connecticut-based largest US subsidiary of Boehringer Ingelheim Corporation and a member of the Boehringer Ingelheim group of companies,  and Eli Lilly and Company announced the US Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5 mg, once-daily) is marketed in the US as Tradjenta (linagliptin) tablets.

Jentadueto is a prescription medication used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. At the maximum dose, Jentadueto demonstrated placebo-corrected reductions in haemoglobin A(1c) (HbA(1c) or A1C) levels of up to 1.7 per cent (+0.1 per cent for placebo and -1.6 per cent for Jentadueto). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. Jentadueto did not cause any meaningful change in body weight. Jentadueto can be used alone or in combination with a sulfonylurea, a commonly prescribed medication for type 2 diabetes. Jentadueto is not for the treatment of type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin. The Jentadueto label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Jentadueto.

"Most people with type 2 diabetes require more than one medication to help lower their blood sugar, due to the complex nature of type 2 diabetes," said Lance Sloan, MD, Texas Institute for Kidney and Endocrine Disorders. "The approval of Jentadueto is exciting because it combines two diabetes medications in a single tablet, making it a good option for people who need an additional medication, and for whom both linagliptin and metformin is appropriate."

Jentadueto was approved based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of Jentadueto was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects.

"We are proud to bring this important, new, single-tablet treatment option, taken twice-daily, to the millions of people currently living with type 2 diabetes," said David Pass, PharmD, vice president, cardiovascular and metabolic disorders marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We are hopeful that Jentadueto, the newest member of the growing family of products from the Boehringer Ingelheim and Lilly diabetes alliance, may help people living with blood sugar levels that are not controlled."

The FDA approval of Jentadueto marks the second US approval since the formation of the Boehringer Ingelheim and Lilly worldwide diabetes alliance in January 2011. The alliance leverages the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic.  

Jentadueto is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. Jentadueto can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

Jentadueto combines two medicines that demonstrated improvements in blood sugar control: the DPP-4 inhibitor, linagliptin, and metformin. Linagliptin (5 mg, once-daily) is marketed in the US as Tradjenta.

Tradjenta has demonstrated significant reductions in A1C when used as monotherapy and in combination with metformin, sulfonylurea and pioglitazone. Metformin is a commonly used antihyperglycemic medication that improves glucose tolerance by lowering both basal and postprandial plasma glucose.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on four 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.