BI and Lilly report positive data from CAROLINA trial

Boehringer Ingelheim and Eli Lilly and Company’s CAROLINA trial met its primary endpoint of non-inferiority for linagliptin (11.8%) compared with glimepiride (12%) in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE). In the secondary endpoint of 3P-MACE plus hospitalisation for unstable angina, linagliptin was similar to glimepiride. 16% of patients in the linagliptin group achieved the secondary composite efficacy endpoint of treatment sustainability versus 10.2% in the glimepiride group. Linagliptin demonstrated similar overall effects on HbA1c to glimepiride, but significantly reduced the relative risk for hypoglycaemia by 77%, which 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, and its overall safety profile was consistent with previous data, with no new safety signals observed.

Corporate Vice President and Head of Cardiovascular & Metabolic Medicine at BI, Waheed Jamal, said: “CAROLINA is unique in that it is the only DPP-4 inhibitor cardiovascular outcome trial with an active comparator. 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.”

Vice President, Product Development at Lilly Diabetes, Jeff Emmick, said: “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. 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.”