An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Renal Insufficiency

In brief

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.

Key facts

Study ID

NCT01064414

Run by

Janssen Research & Development, LLC

People needed

272

Starts

2010-06-01

Expected to finish

2012-08-01

Last updated by the study team

2013-08-14

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents)
• Patients with reduced kidney function

You may not qualify if…

• History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
• Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
• Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen
• History of a severe hypoglycemic episode within 6 months before screening

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Nampa, Idaho, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Jackson, Mississippi, United States
• Study site — Picayune, Mississippi, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Durham, North Carolina, United States
• Study site — Canal Fulton, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Zanesville, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Meridian, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — North Charleston, South Carolina, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Concord, California, United States

Full record on ClinicalTrials.gov

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