Status:
COMPLETED
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Diabetes Mellitus, Type II
Diabetes Mellitus, Non Insulin Dependent
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00642278
Start Date
April 1 2008
End Date
January 1 2009
Last Update
July 19 2013
Active Locations (78)
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1
Birmingham, Alabama, United States
2
Mesa, Arizona, United States
3
Tucson, Arizona, United States
4
Encinitas, California, United States