Janssen Research & Development (Janssen) has started a global, multicentre CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) trial of Invokana (canagliflozin) in patients with type 2 diabetes and diabetic nephropathy.
Around 3,700 patients are expected to be enrolled in the randomised, double-blind, placebo-controlled, parallel group Phase III study.
The main aim of the trial is to examine whether canagliflozin can slow the progression of diabetic nephropathy, a form of renal impairment that is the major cause of end-stage renal disease worldwide.
Janssen canagliflozin compound development team leader Norman Rosenthal said 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% mortality rate over a five-year period," Rosenthal said.
"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."
Patients with type 2 diabetes and diabetic nephropathy receiving standard of care, which includes treatment with angiotensin converting enzyme inhibitors or angiotensin receptor blockers will be evaluated in the CREDENCE trial.
The composite primary endpoint of the trial includes a doubling of serum creatinine, the occurrence of end-stage renal failure and cardiovascular death.
The company is partnering with The George Institute, an academic research organisation based in Sydney, Australia, to offer leadership for the trial.
Invokana is the first oral medication to be available in the US that selectively inhibits sodium glucose co-transporter 2 (SGLT2).
SGLT2 is a cell transporter responsible for the reabsorption of glucose by the kidney, promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes.
Invokana received FDA approval in March 2013 as a single agent as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes.
Most common adverse events with Invokana are genital mycotic (fungal) infections, urinary tract infections and increased urination.
Image: Nodular glomerulosclerosis in the kidney of a patient with diabetic nephropathy. Photo: courtesy of BetacommandBot.