Eli Lilly, Boehringer Ingelheim report CARMELINA trial met primary endpoint
CARMELINA, the "CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk" trial, met its primary endpoint, defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, with Tradjenta demonstrating similar cardiovascular safety compared with placebo, reported Boehringer Ingelheim and Eli Lilly. The trial, which evaluated the impact of treatment with Tradjenta compared with placebo on cardiovascular safety on top of standard of care, 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. "Tradjenta demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function. CARMELINA provides confidence in Tradjenta as an effective and well-tolerated treatment, with a simple dosing regimen, for adults with type 2 diabetes," said Jeff Emmick, vice president, Product Development, Lilly Diabetes. The full results of CARMELINA will be presented on Oct. 4 at the 54th European Association for the Study of Diabetes Annual Meeting.