Status:
COMPLETED
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 c...
Detailed Description
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
1452 Patients enrolled
Trial Details
Trial ID
NCT00968812
Start Date
September 1 2009
End Date
January 1 2013
Last Update
January 30 2017
Active Locations (138)
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1
Calera, Alabama, United States
2
Gilbert, Arizona, United States
3
Mesa, Arizona, United States
4
Tucson, Arizona, United States