Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced enrollment of the first patient into a cardiovascular (CV) and renal outcomes trial for linagliptin (tradjenta) tablets.

The CARMELINA (CArdiovascular Safety & Renal Microvascular outcomE study with LINAgliptin, 5mg 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 Center 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 enroll more than 8,000 adults with T2D in 24 countries at more than 500 sites around the world. The CV endpoint will be 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). Completion of the study is expected in 2018.