Janssen Starts CREDENCE Study For Canagliflozin And Type 2 Diabetes

Janssen Research & Development, LLC announced via press release that it has started CREDENCE trials to study Invokana (canagliflozin). The global Phase III study will determine if the drug is effective in slowing diabetic nephropathy progression in people with type 2 diabetes. Norman Rosenthal, MD, FACE, FACP,

and team leader at Janssen 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 percent mortality rate over a five‐year period.”

Type 2 Diabetes and Diabetic Nephropathy

Type 2 diabetes is a prevalent condition wherein the body is unable to metabolize glucose due to insufficient production of insulin. Close to four million people are living with diabetes and 90 percent of cases are type 2. Diabetic nephropathy is a renal impairment caused by diabetes. Damaged kidneys fail at filtering waste products, leading to kidney disease. 

Invokana

Invokana is a prescription medicine for people with type 2 diabetes, to be used in conjunction with positive diet and exercise habits. The drug is not for type 1 diabetes, those with diabetic ketoacidosis, or those under 18 years old.  Invokana is an oral medication and a sodium glucose transporter that inhibits SGLT2, which promotes glucose loss in the urine. The FDA approved Invokana in 2013 and it is now widely used by endocrinologists. The drug is approved in Europe, Australia, Chile, Mexico, and Switzerland.

The recommended starting dose is 100 mg. Side effects include urinary tract infections, increased urination, and genital mycotic (fungal) infections. Symptoms were mild to moderate in intensity, and led few people to drop out of the studies.

CREDENCE Trial

The CREDENCE trial (Canagliflozin and Renal Events in Diabetes with Established 

Nephropathy Clinical Evaluation) is a Phase III multi-center study and placebo-controlled. Investigators hope to enroll about 4,000 people with type 2 diabetes and nephropathy. The purpose of the study is to determine if Invokana is able to slow diabetic nephropathy progression.

The George Institute from Sydney, Australia will assist in the study. The company works with others in over 50 countries raising millions of dollars for health research. The SCImago Institution Rankings World Report in 2011–2013 rated the institute as one of the top 10 research institutions in the world.