A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

Key facts

Study ID

NCT01106651

Run by

Janssen Research & Development, LLC

People needed

716

Starts

2010-06-01

Expected to finish

2013-05-01

Last updated by the study team

2014-11-04

Who can join

Age: 55 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients must have a diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s)
• Patients in the study must have a HbA1c between >=7 and <=10.0%
• Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

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, or a severe hypoglycemic episode within 6 months before screening

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Carmichael, California, United States
• Study site — Citrus Heights, California, United States
• Study site — Fair Oaks, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Fleming Island, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Wichita, Kansas, United States
• Study site — Waltham, Massachusetts, United States
• Study site — Pahrump, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Cary, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Bismarck, North Dakota, United States
• Study site — Franklin, Ohio, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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