Boehringer Ingelheim and Eli Lilly and Company recently announced plans for a large clinical outcomes trial that will explore empagliflozin (Jardiance) in patients with chronic kidney disease, according to a press release.
 
The companies plan to include patients with and without type 2 diabetes who have chronic kidney disease in the trial.
 
“Our plans for this new trial are yet another example of our ongoing commitment to improving patient health, especially in areas where unmet needs exist,” said Hans-Juergen Woerle, global vice president of medicine, Boehringer Ingelheim. “We look forward to exploring the potential that empagliflozin may offer for people with chronic kidney disease.”
 
Empagliflozin is indicated to lower blood glucose levels along with diet and exercise. It is the only diabetes drug approved to reduce the risk of cardiovascular death in patients with type 2 diabetes who have heart disease, Borhringer Ingelheim reported.
 
Findings from the EMPA-REG OUTCOME trial showed that treatment with empagliflozin reduced the risk of cardiovascular death by 38% compared with placebo. The study also showed that the drug reduced the risk of new or worsening kidney disease by 39% compared with placebo.
 
While the trial was not originally intended to assess the mechanisms of the drug on chronic kidney disease, the kidney assessment was part of a pre-specified analysis of additional endpoints, according to the release.
 
Based on the positive results observed, the manufacturers decided to pursue to use of empagliflozin in patients with chronic kidney disease. The new study plus ongoing mechanistic studies will allow the companies to investigate the potential mechanisms empagliflozin may alter to improve renal outcomes, according to the release.
 
Approximately two-thirds of chronic kidney disease incidences are related to diabetes, hypertension, and obesity. This condition has been linked to morbidity and mortality. It affects 15% of adults living in the United States and costs more than $48 billion each year.
 
Due to limited treatment options, the unmet clinical needs of these patients are growing, according to the release.
 
“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, MD, PhD, vice president, Product Development, Lilly Diabetes.