A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Albuminuria

In brief

The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

Key facts

Study ID

NCT01989754

Run by

Janssen Research & Development, LLC

People needed

5813

Starts

2014-01-16

Expected to finish

2017-02-23

Last updated by the study team

2018-12-11

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a diagnosis of type 2 diabetes mellitus
• Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening)
• Greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
• Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels.

You may not qualify if…

• History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• History of one or more severe hypoglycemic episode within 6 months before screening
• History of hereditary glucose-galactose malabsorption or primary renal glucosuria
• Ongoing, inadequately controlled thyroid disorder
• Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
• Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.

Where it is running

• Study site — Carmichael, California, United States
• Study site — Concord, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Roseville, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Opa-locka, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Meridian, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Topeka, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Mandeville, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — Elkridge, Maryland, United States
• Study site — Flint, Michigan, United States
• Study site — Picayune, Mississippi, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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