Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company have announced enrollment of first patient into a cardiovascular (CV) and renal outcomes trial for linagliptin (TRADJENTA) tablets. The CARMELINA (CArdiovascular Safety & Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk) trial will investigate the effect of the once-daily dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin on cardiovascular and renal outcomes in adults with type 2 diabetes (T2D) at risk of major macro- and microvascular events.

"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 Centre at Medical City in Dallas and principal investigator of the study. "CARMELINA will investigate both cardiovascular and renal outcomes with a DPP-4 inhibitor."

The CARMELINA study will look to enroll more than 8,000 adults with T2D in 24 countries at more than 500 sites around the world. The CV endpoint will be time to the first occurrence of either CV death (including fatal stroke and fatal myocardial infarction [MI, also known as a heart attack]); non-fatal MI; non-fatal stroke; or hospitalization for unstable angina pectoris (unpredictable chest pain produced when the heart is not getting enough blood). The renal, or kidney, outcome is measured as time to first occurrence of renal death, sustained end-stage renal disease or sustained decrease of > /=50% in estimated glomerular filtration rate (eGFR, a measure of kidney function that estimates the amount of blood the kidneys are filtering each minute).1 Completion of the study is expected in 2018.

"Boehringer Ingelheim and Lilly are committed to patient safety, and we are pleased the first patient has been enrolled in the CARMELINA trial," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Clinical trials like CARMELINA provide physicians with information they need to better understand the safety and efficacy of linagliptin, so that they can appropriately treat people with uncontrolled T2D."

CARMELINA 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 T2D who are at high risk of major macro- and microvascular events. Adults with T2D and previous CV complications and albuminuria, which is too much protein in the urine (urine albumin-to-creatinine ratio [UACR] > /= 30 mg/g), and/or evidence of renal microvascular-related end-organ damage (eGFR 15- < 45 with any UACR or eGFR > /= 45-75 with an UACR > 200 mg/g) will be randomized into the study.

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. 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). TRADJENTA has not been studied in patients with a history of pancreatitis and it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA or any other antihyperglycemic drug.

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

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 diabetes 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.

Boehringer Ingelheim Pharmaceuticals, Inc., is one of the world's 20 leading pharmaceutical companies and is committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

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.