Commercial sponsors Eli Lilly and Boehringer Ingelheim reported on the CAROLINA study (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes), which met its primary endpoint. The endpoint is defined as non-inferiority for Tradjenta (linagliptin) versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE). CAROLINA is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor.
The trial evaluated the cardiovascular safety of Tradjenta (5 mg once daily) 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.