DPP-4 inhibitor meets primary endpoint in CV outcome trial
The CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes (CAROLINA) trial met its primary endpoint, defined as non-inferiority of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin compared to the sulfonylurea glimepiride in time to first occurrence of CV death, non-fatal MI or non-fatal stroke (3P-MACE).
The CAROLINA trial evaluated the CV safety of linagliptin (5 mg once daily) compared to the sulphonylurea glimepiride, on top of standard of care in 6,033 adults with T2DM and increased CV risk or established CVD. The trial assessed linagliptin safety with a median follow-up of more than 6 years. The overall safety profile of linagliptin in CAROLINA was consistent with previous data and no new safety signals were observed.
CAROLINA is a multi-national, randomized, double-blind, active-controlled clinical trial that involved 6,033 adults with T2DM from 43 countries at more than 600 sites observed for a median duration of more than 6 years. The trial included adults with early T2DM: adults with a median disease duration of 6.2 years, who either received no treatment at all, or received 1-2 glucose lowering agents (e.g. metformin). The trial was designed to assess the effect of linagliptin 5 mg once daily on CV safety in adults with T2DM and increased CV risk or established CVD, compared to the sulphonylurea glimepiride (both on stable background glucose-lowering medication and CV standard of care).