Eli Lilly, Boehringer Ingelheim announce CAROLINA trial meets primary endpoint
Boehringer Ingelheim and Eli Lilly announced CAROLINA met its primary endpoint, defined as non-inferiority for Tradjenta versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. CAROLINA is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4, or DPP-4, inhibitor. The trial evaluated the cardiovascular safety of Tradjenta compared with the sulfonylurea glimepiride, on top of standard of care, in 6,033 adults with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease. The study assessed Tradjenta safety over the longest period ever studied in a DPP-4 inhibitor cardiovascular outcome trial, with a median follow-up of more than 6 years. The overall safety profile of Tradjenta in CAROLINA was consistent with previous data, and no new safety signals were observed. People with type 2 diabetes have an increased risk of cardiovascular disease, and despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for this population. Together with CARMELINA, which demonstrated similar long-term cardiovascular safety compared with placebo in adults with type 2 diabetes at high risk for cardiovascular and/or kidney disease, CAROLINA confirms the long-term overall safety profile of Tradjenta in a broad range of adults with type 2 diabetes.