Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today presented the full results of the long-term cardiovascular outcome trial, CARMELINA®, which studied the impact of Trajenta® (linagliptin) on cardiovascular and kidney safety in adults with type 2 diabetes at high risk for heart and/or kidney disease. The study met its primary endpoint,* with linagliptin demonstrating a similar cardiovascular safety profile compared to placebo when added to standard of care.CARMELINA® also included a key secondary composite endpoint,† showing a similar kidney safety profile compared to placebo.
The overall safety profile of linagliptinin CARMELINA® was consistent with previous data and no new safety signals were observed. CARMELINA® also showed a similar rate of hospitalisation for heart failure for linagliptin compared to placebo.
The full results were presented at the 54th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany.
“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, but whom we see in our daily practice. The trial confirmed that linagliptin can be used with confidence in this patient population,” commented 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.
In CARMELINA®, cardiovascular events that contributed to the primary endpoint occurred in 12.4 percent (434 people) of the linagliptingroup compared to 12.1 percent (420 people) in the placebo group, demonstrating a similar long-term cardiovascular safety profile in adults with type 2 diabetes. Linagliptin also showed a similar long-term kidney safety profile compared to placebo. This was demonstrated on the composite endpoint reflecting declining kidney function† occurring in 9.4 percent (327 people) of the linagliptin group compared to 8.8 percent (306 people) of the placebo group.
An increase in the risk of hospitalisation for heart failure has been observed in some other cardiovascular outcome trials in diabetes.In CARMELINA®, this endpoint was pre-specified and assessed thoroughly via adjudication. Hospitalisation for heart failure occurred in 6 percent (209 people) of the linagliptin group compared to 6.5 percent (226) of the placebo group. “These results are particularly meaningful given the patient population in CARMELINA, including those most vulnerable to developing heart failure,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
“While many guidelines now recognise the importance of choosing a diabetes treatment with a proven benefit on reducing cardiovascular risk and mortality in people with type 2 diabetes and heart disease, there remains a need for additional glucose-lowering options,” Waheed Jamal pointed out. “CARMELINA® reinforces confidence in linagliptin as an effective and well-tolerated treatment, with a simple dosing regimen for adults with type 2 diabetes.”
“We have created a unique cardiovascular outcome trial programme for linagliptin with two trials — CARMELINA®, whose results are released today, as well as CAROLINA®, which will report initial results in the near future,” added Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly Diabetes. “This programme will provide clinical data on the long-term safety profile of linagliptin in a broad range of adults with type 2 diabetes, which reflects patients that doctors see in their daily practice.”