Boehringer Ingelheim and Eli Lilly and Company plan to conduct a new, large clinical outcomes trial investigating Jardiance (empagliflozin) tablets for the treatment of people with chronic kidney disease. The trial will enroll people with chronic kidney disease both with and without type 2 diabetes.
Jardiance is the first and only type 2 diabetes medicine approved to reduce the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease. The landmark EMPA-REG OUTCOME trial demonstrated that Jardiance reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs).
As one of the secondary endpoints, the trial also showed that Jardiance reduced the risk for new-onset or worsening of kidney disease by 39 percent versus placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease. Based on these results, BI and Lilly decided to formally investigate the potential of JARDIANCE in people with chronic kidney disease.
"Based on the cardiovascular and renal results of the EMPA-REG OUTCOME trial, we, along with Boehringer Ingelheim, look forward to starting this new trial to gather evidence in support of a potential new indication for empagliflozin in people with chronic kidney disease," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes.