FDA approves Jentadueto™ (linagliptin/metformin hydrochloride) tablets for the treatment of adults with Type 2 Diabetes

FDA approves Jentadueto™ (linagliptin/metformin hydrochloride) tablets for the treatment of adults with Type 2 Diabetes :

Ingelheim, Germany and Indianapolis, USA, 31 January, 2012 – Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) have announced that the U.S. 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. ¹ Linagliptin/metformin hydrochloride (HCl) provides a new, single-tablet treatment option, taken twice-daily, for adults with Type 2 Diabetes who need to improve control of their blood glucose. ¹ Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta™ (linagliptin) tablets, as Trajenta™ across Europe and Canada, and Trazenta™ in Japan, as well as in further markets. ^2,3

Linagliptin/metformin HCl is a prescription medication used along with diet and exercise to improve glycaemic control in adults with Type 2 Diabetes when treatment with both linagliptin and metformin is appropriate. At the maximum dose, linagliptin/metformin HCl demonstrated placebo-corrected reductions in haemoglobin A _1c (HbA _1c or A1C) levels of up to 1.7 percent (+0.1 percent for placebo and -1.6 percent for linagliptin/metformin HCl). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. Linagliptin/metformin HCl did not cause any meaningful change in body weight. Linagliptin/metformin HCl can be used alone or in combination with a sulphonylurea, a commonly prescribed medication for Type 2 Diabetes. Linagliptin/metformin HCl are 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 linagliptin/metformin HCl 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 linagliptin/metformin HCl. ¹

"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 Dr. Lance Sloan, 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."

Linagliptin/Metformin HCl Clinical Trials In a 24-week, randomised, double-blind, placebo-controlled factorial study evaluating 791 adults with Type 2 Diabetes and inadequate glycaemic control with diet and exercise, linagliptin plus metformin demonstrated the following: ¹

Glycaemic parameters at final visit (24-week study) for linagliptin and metformin, alone and in combination in randomised adults with Type 2 Diabetes Mellitus inadequately controlled on diet and exercise (full analysis population using last observation on study)

*Fasting plasma glucose (FPG) is used to determine glucose levels in a fasting state (usually upon waking in the morning).

Linagliptin/metformin HCl tablets were approved based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of linagliptin/metformin HCl was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects. ¹

Adverse reactions reported in greater than or equal to five percent of patients treated with linagliptin/metformin HCl and more commonly than in patients treated with placebo included nasopharyngitis (the common cold) and diarrhoea. Hypoglycaemia was more commonly reported in patients treated with the combination of linagliptin/metformin HCl and sulphonylurea compared with those treated with the combination of placebo, sulphonylurea and metformin (22.9 percent versus 14.8 percent, respectively). Pancreatitis was reported more often in patients randomised to linagliptin (1 per 538 person years versus zero in 433 person years for comparator). ¹

"We are proud to bring this important, new treatment option combining linagliptin and metformin hydrochloride as a single-tablet, taken twice-daily, to the millions of people currently living with Type 2 Diabetes," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "We are hopeful that Jentadueto™, the newest member of the growing family of products from the Boehringer Ingelheim and Lilly diabetes alliance, will help people living with blood glucose levels that are not adequately controlled."
The FDA approval of linagliptin/metformin HCl marks the second U.S. approval since the formation of the Boehringer Ingelheim and Eli Lilly and Company 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.
About linagliptin/metformin HCl Linagliptin/metformin HCl is a prescription medicine that contains two diabetes medicines, linagliptin and metformin. Linagliptin/metformin HCl can be used along with diet and exercise to help control blood glucose in adults with Type 2 Diabetes when treatment with both linagliptin and metformin is appropriate. ¹ Linagliptin/metformin HCl is not for people with Type 1 Diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). ¹ It is not known if linagliptin/metformin HCl is safe and effective when used with insulin. ¹
About Linagliptin Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase-4) which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homoeostasis. ³
Linagliptin (5 mg, once-daily) is marketed in the U.S. as Tradjenta™, as Trajenta™ across Europe and Canada, and Trazenta™ in Japan, as well as in further markets. ^2,3
Linagliptin is a prescription medicine that is used along with diet and exercise to lower blood glucose in adults with Type 2 Diabetes. ^2,3 Linagliptin is not for people with Type 1 Diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). ^2,3 It is not known if linagliptin is safe and effective when used with insulin. ^2,3

About Diabetes An estimated 366 million people worldwide have diabetes. ⁴ Type 2 Diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases. ⁴ Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin. ⁵

Boehringer Ingelheim and Eli Lilly and Company 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. Find out more about the alliance.

About Boehringer Ingelheim The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24 percent of net sales in its largest business segment Prescription Medicines on research and development.

About Eli Lilly and Company 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. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. 

About Lilly Diabetes For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world's first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy – practical tools, education, and support programmes to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours. 

This press release contains forward-looking statements about linagliptin and linagliptin/metformin HCl tablets for the treatment of Type 2 Diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that linagliptin will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.