Boehringer Ingelheim and Eli Lilly and Company presented the full results of the long-term cardiovascular outcome trial, CARMELINA, which studied the impact of Tradjenta 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 54th European Association for the Study of Diabetes Annual Meeting in Berlin.
"Heart disease is a major complication and the leading cause of death for people living with type 2 diabetes. CARMELINA adds important new evidence for type 2 diabetes patients at high risk of heart and/or kidney disease, a population that has been underrepresented in other cardiovascular outcome trials with diabetes, but whom we see in our daily practice," said Bernard Zinman, M.D., professor in the Department of Medicine, University of Toronto and senior scientist at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada.
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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.
"Diabetes is a complex condition to manage and there remains a need for treatments with proven long-term cardiovascular and renal outcomes," said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The CARMELINA results reinforce confidence in Tradjenta as an effective and well-tolerated treatment and are particularly meaningful for those most vulnerable to serious complications, including heart failure and kidney disease."