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

• Status: Completed
• Trial end date: 2017-02-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: The George Institute for Global Health, Australia
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria

• 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.