Jardiance (empagliflozin) meets endpoint in trial of CV outcomes in type 2 diabetes- Boehringer/Eli Lilly

Boehringer and Eli Lilly announced positive top-line results from EMPA-REG OUTCOME, a long-term clinical trial investigating cardiovascular (CV) outcomes for Jardiance (empagliflozin) in more than 7,000 adults with type 2 diabetes (T2D) at high risk for CV events. EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of Jardiance, when added to standard of care, in CV risk reduction. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke. EMPA-REG OUTCOME was a multicentre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 individuals from 42 countries observed for a median duration of 3.1 years.

The study was designed to assess the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care on CV events in adults with T2D at high risk of CV events and with less than optimized blood glucose control. The study was designed to first test for non-inferiority and then for superiority. The safety profile of Jardiance was consistent with previous studies. Detailed study results will be presented at the 51st EASD Annual Meeting.