INGELHEIM, Germany I July 31, 2013 I Boehringer Ingelheim (BI) and Eli Lilly and Company today announced enrollment of the first patient into a cardiovascular and renal outcomes trial for linagliptin (Trajenta®). The CARMELINA1 (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with Type 2 Diabetes mellitus at high vascular risk) trial will investigate the once daily dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, on cardiovascular and renal microvascular outcomes in adults with Type 2 Diabetes at risk of cardiovascular and renal events.
Linagliptin (5 mg, once daily) is a once-daily tablet that is used along with diet and exercise and other drug therapies to improve glycaemic control in adults with Type 2 Diabetes.
“Diabetes is a major risk factor for cardiovascular disease, as well as a leading cause of chronic renal failure,” said Dr. Julio Rosenstock, Director of the Dallas Diabetes and Endocrine Center at Medical City in Dallas and Principal Investigator of the study. “CARMELINA will investigate both cardiovascular and renal safety with a DPP-4 inhibitor on adverse cardiovascular and renal outcomes.”
The CARMELINA study will include more than 8,000 adults with Type 2 Diabetes in 24 countries at more than 500 sites around the world.1 The primary endpoint will be time to the first occurrence of either CV death (including fatal stroke and fatal MI); non-fatal MI; non-fatal stroke; or hospitalisation for unstable angina pectoris (AP). The renal outcome is measured as a composite of renal death, sustained end-stage renal disease and sustained decrease of ≥50 percent eGFR.1 The study is expected to complete in 2018.
“We are delighted that the first patient has now been enrolled in CARMELINA and look forward to continued recruitment and patient follow-up,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The initiation of this trial reinforces our ongoing commitment to evaluate the efficacy and safety of linagliptin, ensuring that treating physicians are provided with all required information to support the use of the treatment in clinical practice as appropriate.”
About CARMELINA
CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with Type 2 Diabetes mellitus at high vascular risk) is a long-term study investigating the efficacy and safety of linagliptin 5 mg once daily versus placebo on cardiovascular and renal microvascular outcomes in people with Type 2 Diabetes who are at risk of cardiovascular events. Adults with Type 2 Diabetes and previous CV complications and albuminuria (UACR ≥30mg/g) and/or evidence of microvascular related end-organ damage (eGFR 15-200mg/g) will be randomised into the study.
About Linagliptin
Linagliptin is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin tablets), as a once-daily tablet (5mg) that is used along with diet and exercise to improve glycaemic control in adults with Type 2 Diabetes. Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).2,3
About Diabetes
An estimated 371 million people worldwide have Type 1 and Type 2 Diabetes.4 Type 2 Diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases.5 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.6
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 centers on three 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 at www.boehringer-ingelheim.com or www.lilly.com.
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 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.Social responsibility is a central element of Boehringer Ingelheim’s culture. 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 endeavors.In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5 percent of its net sales.For more information please visit www.boehringer-ingelheim.comAbout 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 organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions – from medicines to support programs and more – to make lives better.
For more information, visit www.lillydiabetes.com
This press release contains forward-looking statements about linagliptin 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 commercialisation. 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.
References1 Clinical Trials: CARMELINA: CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with Type 2 Diabetes mellitus at high cardiovascular risk
2 Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011
3 EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011
4 International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
5 World Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html#
6 International Diabetes Federation. What is Diabetes IDF Diabetes Atlas. 2011; (5th Edition).
SOURCE: Boehringer Ingelheim
