Boehringer Ingelheim and Lilly announced that the CAROLINA trial met its primary endpoint, demonstrating no increased cardiovascular (CV) risk with linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, when compared with glimepiride, a sulfonylurea, in patients with type 2 diabetes and CV risk. 

The multinational, randomized, double-blind, active-controlled CAROLINA (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) trial (N=6033) evaluated the CV safety of linagliptin (5mg once daily) vs glimepiride, in addition to standard of care, in adults with type 2 diabetes at increased CV risk or those with established CV disease; median follow-up was over 6 years. Study participants had early type 2 diabetes (median disease duration of 6.2 years) and were either treatment-naive or received 1-2 glucose-lowering agents. The primary endpoint was time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke.

Regarding safety, the linagliptin profile was consistent with previous data and no new safety signals were reported. Data from CAROLINA further validated the long-term CV safety outcomes observed in CARMELINA, which included type 2 diabetes patients at high risk for heart and kidney disease. Full data are expected to be announced later this year. 

“With these results, CAROLINA expands our understanding of the long-term cardiovascular safety of linagliptin, which now has one of the most comprehensive datasets on the cardiovascular safety of a DPP-4 inhibitor,” stated Waheed Jamal, MD, Corporate Vice President and Head of Cardiovascular & Metabolic Medicine, Boehringer Ingelheim.

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Linagliptin is marketed under the brand name Tradjenta and is currently FDA-approved as an adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy. 

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