Boehringer Ingelheim and Eli Lilly released the positive top-line results from the trial, which evaluated the impact of treatment with Tradjenta compared with placebo on cardiovascular safety on top of standard of care.
The study included 6,979 adults with type 2 diabetes and high cardiovascular risk. The majority of patients also had kidney disease, an important risk factor for cardiovascular disease. The overall safety profile of Tradjenta in CARMELINA, including adults with kidney disease, was consistent with previous data, and no new safety signals were observed.
People who have diabetes are at an increased risk of both cardiovascular disease and chronic kidney disease. Despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for people living with diabetes, and about two-thirds of chronic kidney disease cases are attributable to metabolic conditions, such as diabetes, obesity and hypertension.
“About half of patients with type 2 diabetes worldwide also have chronic kidney disease, and the majority of deaths among people with kidney disease occur as a result of cardiovascular complications,” said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “These CARMELINA data add important information regarding the long-term clinical safety of Tradjenta in a patient population that is particularly vulnerable to poor cardiovascular outcomes.”
“Tradjenta demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function,” added Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. “CARMELINA provides confidence in Tradjenta as an effective and well-tolerated treatment, with a simple dosing regimen, for adults with type 2 diabetes.”