CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

Key facts

Study ID

NCT00968812

Run by

Janssen Research & Development, LLC

People needed

1452

Starts

2009-09-01

Expected to finish

2013-01-01

Last updated by the study team

2017-01-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of type 2 diabetes
• Body mass index (BMI) >=22 to <=45 kg/m2, at screening
• Patients must be taking a stable dosage of metformin as monotherapy at screening
• Patients must have a HbA1c between >=7% and <=9.5% at Week 2
• Patients must have a fasting plasma glucose (FPG) <=270 mg/dL (15 mmol/L) at Week -2

You may not qualify if…

• Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
• 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
• Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
• Taken thiazolidinedione therapy in the past 16 weeks before screening

Where it is running

• Study site — Gilbert, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Buena Park, California, United States
• Study site — Encinitas, California, United States
• Study site — Fresno, California, United States
• Study site — Lincoln, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — Westlake Village, California, United States
• Study site — Chipley, Florida, United States
• Study site — Marianna, Florida, United States
• Study site — Oldsmar, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Perry, Georgia, United States
• Study site — Nampa, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Vernon Hills, Illinois, United States
• Study site — Valparaiso, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Elkridge, Maryland, United States
• Study site — Bloomfield Hills, Michigan, United States
• Study site — Calera, Alabama, United States

Full record on ClinicalTrials.gov

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