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CREDENCE Results for Canagliflozin to Be Presented This Weekend in Australia

AJMC Staff
The findings represent the first in a new wave of renal outcomes trials in the sodium glucose co-transporter 2 (SGLT2) inhibitor class, a game-changing group of type 2 diabetes drugs with many benefits beyond lowering blood glucose.
Investigators will present phase 3 results from the CREDENCE trial late Sunday, which could advance the position of the type 2 diabetes (T2D) drug canagliflozin weeks after Janssen Pharmaceuticals filed with FDA for an indication for chronic kidney disease (CKD) in patients with T2D. The findings will come 6 months after canagliflozin received an indication to reduce the risk of major cardiovascular (CV) events in patients with T2D.
Results for CREDENCE have been anticipated since July 2018, when an independent data monitoring committee ended the trial early after finding that canagliflozin, sold by Janssen as Invokana, met the prespecified criteria for efficacy. The findings from Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) will be presented in Melbourne, Australia, during the 2019 World Congress of Nephrology in Melbourne, Australia, hosted by the International Society of Nephrology.

The CREDENCE trial is the first dedicated phase 3 renal outcomes study of any sodium glucose co-transporter 2 (SGLT2) inhibitor in patients with T2D and CKD in addition to standard of care. The study randomized 4401 patients in a double-blind, event-driven, placebo-controlled, 2-arm, study. All patients had T2D and either stage 2 or stage 3 CKD. This was defined as an estimated glomerular filtration rate (eGFR) of ≥30 to <90 mL/min/ 1.73m2) and macroalbuminuria, defined as urinary albumin-to-creatinine ratio >300 to ≤5000 mg/g), who were receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.

Based on the results from CREDENCE, Janssen announced in a March 28, 2019, statement that it had submitted a supplemental New Drug Application (sNDA) to the FDA seeking a new indication for canagliflozin to reduce the risk of end-stage renal disease (ESRD), the doubling of serum creatine, as well as CV and renal death in adults with CKD and T2D. Canagliflozin is currently contraindicated for patients with severe renal impairment, end-stage renal disease, or patients on dialysis.

James F. List, MD, PhD, global therapeutic area head of Cardiovascular & Metabolism for Janssen said in a statement, “Today, millions of people living with type 2 diabetes and chronic kidney disease are at high risk of experiencing kidney failure, and unfortunately, we have not seen treatment innovation for these patients in almost 20 years. Janssen’s application is a significant step toward bringing a much-needed, new standard of care for those living with these serious conditions. We look forward to presenting the CREDENCE data at the ISN World Congress of Nephrology and working closely with the FDA to bring this important medicine as quickly as possible to people living with type 2 diabetes and chronic kidney disease.”

Besides lowering blood sugar, SGLT2 inhibitors have been found to reduce hypertension, help patients lose modest amounts of weight, and reduce hospitalization for heart failure. After a wave of cardiovascular outcomes trials (CVOTs) revealed unexpected benefits from the class, the American College of Cardiology and the American Heart Association recently added SGLT2 inhibitors to its primary prevention guidelines for patients with T2D and atherosclerotic cardiovascular disease.

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