Long term CARMELINA trial of Tradjenta reports on CV safety and kidney disease in type 2 diabetes. Boehringer + Eli Lilly

Boehringer Ingelheim and Eli Lilly and Company presented the full results of the long-term cardiovascular outcome trial, CARMELINA , which studied the impact of Tradjena on cardiovascular safety and kidney outcomes in adults with type 2 diabetes at high risk for heart and/or kidney disease. The study met its primary endpoint, with Tradjenta demonstrating a similar cardiovascular safety profile compared with placebo when added to standard of care. The overall safety profile of Tradjenta in the trial, including adults with kidney disease, was consistent with previous data and no new safety signals were observed. The full CARMELINA results were presented at the 54thEuropean Association for the Study of Diabetes Annual Meeting in Berlin.

In CARMELINA, cardiovascular events that contributed to the primary endpoint, defined as time to first occurrence of 3-P MACE (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke), occurred in 12.4 percent (434 people) of the Tradjenta group compared with 12.1 percent (420 people) of the placebo group. CARMELINA also included a key secondary composite endpoint, with Tradjenta demonstrating a similar kidney safety profile compared with placebo. This secondary composite endpoint reflecting declining kidney function occurred in 9.4 percent (327 people) of the Tradjenta group compared with 8.8 percent (306 people) of the placebo group. In CARMELINA, the risk of hospitalization for heart failure was examined as a pre-specified endpoint that was subject to adjudication.* Hospitalization for heart failure occurred in 6 percent (209 people) of the Tradjenta group compared with 6.5 percent (226) of the placebo group.