Boehringer Ingelheim, in collaboration with Eli Lilly and Company, is set to evaluate empagliflozin in a new clinical outcomes trial to treat patients suffering from chronic kidney disease.
Marketed under the name Jardiance, empagliflozin is an oral, once-daily, highly selective inhibitor of sodium glucose cotransporter 2 (SGLT2).
The new trial is designed to enrol up to 5,000 chronic kidney disease patients with and without type 2 diabetes.
Boehringer Ingelheim medicine global vice-president Hans-Juergen Woerle said: “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.
“We look forward to exploring the potential that empagliflozin may offer for people with chronic kidney disease.”
The firm previously reported positive results from a long-term, multi-centre, randomised, double-blind, placebo-controlled EMPA-REG OUTCOME trial that investigated the effect of 10mg and 25mg once-daily empagliflozin combined with standard of care glucose-lowering agents and cardiovascular drugs.
Performed in more than 7,000 patients with type 2 diabetes and at high risk for cardiovascular events, the trial’s primary endpoint was time to the first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.
During the trial, empagliflozin was found to minimise the risk of cardiovascular death by 38% and the relative risk for new-onset or worsening of kidney disease by 39%, when compared to placebo.
Eli Lilly diabetes product development vice-president Jeff Emmick said: “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.”