Janssen Research & Development LLC announced the initiation of CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation), a global, multicenter study of Invokana (canagliflozin). This Phase 3 study is a randomized, double-blind, placebo-controlled, parallel group trial designed to enroll more than 3,700 patients with type 2 diabetes and diabetic nephropathy. The objective of the study is to examine whether canagliflozin can slow the progression of diabetic nephropathy, a form of renal impairment that is the most common cause of end-stage renal disease worldwide.
“Nearly one-third of all patients with type 2 diabetes will develop evidence of nephropathy. Despite the availability of existing therapies proven to slow its progression, diabetic nephropathy is associated with a 36 percent mortality rate over a five-year period,” said Norman Rosenthal, canagliflozin compound development team leader, Janssen. “Clearly, patients need new, safe and effective treatment options. We look forward to determining if canagliflozin can be used to treat diabetic nephropathy, as we continue to assess additional uses for canagliflozin.”
The CREDENCE trial will evaluate patients with type 2 diabetes and diabetic nephropathy receiving standard of care, which includes treatment with angiotensin converting enzyme inhibitors or angiotensin receptor blockers. The trial’s composite primary endpoint includes a doubling of serum creatinine, the occurrence of end-stage renal failure and cardiovascular death. Janssen is partnering with The George Institute, a leading Academic Research Organization based in Sydney, Australia, to provide academic leadership for the study.
Date: February 21, 2014