An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type II, Diabetes Mellitus, Non Insulin Dependent

In brief

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.

Key facts

Study ID

NCT00642278

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

451

Starts

2008-04-01

Expected to finish

2009-01-01

Last updated by the study team

2013-07-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c levels >=7% and <=10.5%
• taking a stable daily dose of metformin
• Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
• Stable body weight
• Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L) for women

You may not qualify if…

• Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
• Known contraindication or suspected hypersensitivity to sitagliptin or metformin
• A history of diabetic ketoacidosis or type 1 diabetes mellitus
• History of pancreas or beta-cell transplantation
• History of active proliferative diabetic retinopathy
• History of hereditary glucose-galactose malabsorption or primary renal glucosuria

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Encinitas, California, United States
• Study site — Lincoln, California, United States
• Study site — Los Angeles, California, United States
• Study site — Merced, California, United States
• Study site — Roseville, California, United States
• Study site — Denver, Colorado, United States
• Study site — Golden, Colorado, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Nampa, Idaho, United States
• Study site — Topeka, Kansas, United States
• Study site — Haverhill, Massachusetts, United States
• Study site — Cherry Hill, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New Hyde Park, New York, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Greer, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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