Phase III CAROLINA trial of Tradjenta meets primary endpoint in type 2 diabetes and CV outcomes.- Boehringher + Eli Lilly
Boehringer and Eli Lilly announced phase III trial CAROLINA met its primary endpoint, 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.
Comment: The full results of CAROLINA will be presented on June 10 at the American Diabetes Association's 79th Scientific Sessions.
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