Top-line results from the CAROLINA study released Thursday demonstrated that the DPP-IV inhibitor linagliptin was noninferior vs. glimepiride for time to first major adverse cardiovascular event in adults with type 2 diabetes at high CV risk, according to a press release from Boehringer Ingelheim and Eli Lilly.
The study, the first and only active-comparator CV outcomes trial for a DPP-IV inhibitor, showed that linagliptin (Tradjenta) met its primary endpoint, defined as noninferiority vs. glimepiride in time to first occurrence of CV death, nonfatal myocardial infarction or nonfatal stroke during a median follow-up of 6 years.
The trial evaluated the CV safety of 5 mg once-daily linagliptin vs. glimepiride, in addition to standard of care, in 6,033 adults with type 2 diabetes and increased CV risk or established CVD. The median follow-up was the longest period studied for a DPP-IV inhibitor CV outcomes trial, according to the two companies.
The overall safety profile of linagliptin in CAROLINA was consistent with previous data, and no new safety signals were observed, according to the release.
“Guidelines from the American College of Cardiology and American Diabetes Association recommend type 2 diabetes treatments with proven cardiovascular benefits for patients with established cardiovascular disease,” Thomas Seck, MD, senior vice president for medicine and regulatory affairs at Boehringer Ingelheim, said in the release. ”But physicians considering additional therapies to lower glucose values for their patients need a DPP-IV inhibitor with an established long-term safety profile. Along with CARMELINA, CAROLINA provides Tradjenta with one of the most comprehensive data sets on the safety of a DPP-IV.”
The findings follow data from the CARMELINA trial presented in October at the European Association for the Study of Diabetes and reported by Endocrine Today. In that study, linagliptin demonstrated CV safety and a neutral effect for hospitalization for heart failure and kidney outcomes vs. placebo among adults with type 2 diabetes, established CVD and/or chronic kidney disease.
“These data provide further confidence in the well-established safety and tolerability profile of Tradjenta for the treatment of adults with type 2 diabetes,” Jeff Emmick, MD, PhD, vice president of product development for Lilly Diabetes, said in the release. “Tradjenta is an important option for physicians considering a DPP-IV inhibitor for their patients with type 2 diabetes.”
The full results of CAROLINA will be presented June 10 at the ADA’s 79th Scientific Sessions in San Francisco. – by Regina Schaffer
Disclosures: Emmick reports he is vice president of product development for Lilly Diabetes. Seck reports he is senior vice president for medicine and regulatory affairs at Boehringer Ingelheim.