Boehringer Ingelheim and Eli Lilly announced Thursday that a cardiovascular outcome study of Tradjenta (linagliptin) met its primary endpoint, with the DPP-4 inhibitor demonstrating no increased cardiovascular risk versus Sanofi's Amaryl (glimepiride) in adults with type 2 diabetes and cardiovascular risk. Full results from the CAROLINA trial will be presented later this year at the American Diabetes Association's scientific sessions.
In the study, 6033 adults with early type 2 diabetes were randomly assigned to treatment with Tradjenta or Amaryl, on top of standard of care, with the main goal defined as non-inferiority in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. With a median follow-up exceeding six years, the drugmakers noted that the study represents the longest period ever for a DDP-4 inhibitor cardiovascular outcomes trial.
Boehringer Ingelheim and Eli Lilly stated that the overall safety profile of Tradjenta in the CAROLINA trial was consistent with previous findings, with no new safety signals uncovered. Jeff Emmick, vice president of product development for Eli Lilly's diabetes segment, said "these data provide further confidence in the well-established safety and tolerability profile of Tradjenta for the treatment of adults with type 2 diabetes."
The results come after the companies unveiled data from the long-term cardiovascular outcome trial CARMELINA last October illustrating that Tradjenta was associated with a similar safety profile as placebo when added to standard of care in adults with type 2 diabetes at high risk for heart and/or kidney disease.
Tradjenta was initially approved by the FDA in 2011 for the treatment of adults with type 2 diabetes, with the therapy later authorised for the same indication in Europe, where it is marketed under the name Trajenta. The drug was jointly developed by Boehringer Ingelheim and Eli Lilly under the terms of a 2011 partnership.
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