Findings from the CARMELINA (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk) trial showed that linagliptin (Tradjenta; Boehringer Ingelheim and Lilly) met the primary endpoint, demonstrating cardiovascular (CV) safety similar to placebo.
The multinational, double-blind, randomized, placebo-controlled study (N=6979) included adult patients with type 2 diabetes and high CV risk and set out to evaluate the impact of linagliptin vs placebo on CV safety when added to standard of care; patients were followed for a median duration of 2.2 years. The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3-point MACE). A secondary endpoint looked at the effect of linagliptin vs placebo on renal outcomes in adults with type 2 diabetes and high CV risk.
Results showed the overall safety profile of linagliptin in study patients, including adults with kidney disease, was consistent with previous data. There were no new safety signals identified during the study.
Tradjenta, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
“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, MD, PhD, vice president, Product Development, Lilly Diabetes.
For more information call (800) 243-0127 or visit Tradjenta.com.