Boehringer Ingelheim and Eli Lilly have announced full data from the CAROLINAtrial, in which Trajenta (linagliptin) demonstrated no increased cardiovascular risk compared to glimepiride in adults with type II diabetes and cardiovascular risk.
The study is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor, and also 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 six years.
In the trial a higher proportion of patients within the linagliptin group - 16% - achieved the secondary composite efficacy endpoint of treatment sustainability, compared to 10.2% in the glimepiride group.
The secondary composite efficacy outcome, which it also met, was defined as HbA1c at or below 7% at the final visit without rescue medication, moderate or severe hypoglycaemia or a 2% or greater weight gain.
“The American Diabetes Association and European Association for the Study of Diabetes recommend type II diabetes treatments with proven cardiovascular benefits for patients with established cardiovascular disease,” said Jeff Emmick, VP product development, Lilly Diabetes.
He continued, “But, physicians considering additional therapies to lower blood glucose for their patients need an additional agent 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 adult patients with type II diabetes.”
The findings were reported at the American Diabetes Association’s 79th Scientific Sessions in San Francisco.