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. 

Continue Reading

“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.

Related Articles

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. 

For more information visit or

Follow @EndoAdvisor

This article originally appeared on MPR