Full data from CAROLINA® outcome trial support long-term cardiovascular safety profile of Trajenta®

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced full data from the CAROLINA^® trial demonstrating that Trajenta^® (linagliptin) did not increase cardiovascular risk compared to glimepiride in adults with type 2 diabetes and cardiovascular risk. The findings were reported today at the American Diabetes Association’s 79th Scientific Sessions in San Francisco.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190610005823/en/

The trial met its primary endpoint, defined as non-inferiority for linagliptin versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE), which occurred in 11.8 percent (356 people) of the linagliptin group compared to 12.0 percent (362 people) of the glimepiride group.¹ The overall safety profile of linagliptin in CAROLINA^® was consistent with previous data, and no new safety signals were observed.

The study assessed linagliptin 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. Linagliptin was similar to glimepiride in the secondary endpoint of 3P-MACE plus hospitalisation for unstable angina (4P-MACE - 13.2 percent for linagliptin versus 13.3 percent for glimepiride).

In CAROLINA^®, a higher proportion of patients within the linagliptin group (16.0 percent) achieved the secondary composite efficacy endpoint of treatment sustainability versus the glimepiride group (10.2 percent). Compared with glimepiride, linagliptin demonstrated similar overall effects on HbA1c, but significantly reduced the relative risk for hypoglycaemia (low blood sugar) by 77 percent (10.6 percent of patients treated with linagliptin experienced any hypoglycaemic incident versus 37.7 percent for glimepiride). This risk reduction was consistent and significant across all hypoglycaemia categories, including severe hypoglycaemia and those requiring hospitalisation. Linagliptin was also associated with a modest weight reduction of 1.5 kg versus glimepiride.

“CAROLINA^® is unique in that it is the only DPP-4 inhibitor cardiovascular outcome trial with an active comparator,” said Waheed Jamal, MD, Corporate Vice President and Head of Cardiovascular & Metabolic Medicine, Boehringer Ingelheim. “When additional glucose-lowering is needed, DPP-4 inhibitors and sulfonylureas continue to be frequently used as add-on therapies to metformin. These data can further support physicians in choosing the most appropriate glucose-lowering treatment for each individual patient.”

“The American Diabetes Association and European Association for the Study of Diabetes recommend type 2 diabetes treatments with proven cardiovascular benefits for patients with established cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly Diabetes. “But, physicians considering additional therapies to lower blood glucose for their patients need a DPP-4 inhibitor with an established long-term safety profile. These new data from CAROLINA^®, along with data from the placebo-controlled cardiovascular outcome trial CARMELINA^®, expand the evidence and experience with linagliptin, to provide healthcare professionals with confidence in the long-term safety profile across a broad range of patients with type 2 diabetes.”