Tracking Information
Start Date ICMJE | August 2009 |
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Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 28, 2009) | The primary efficacy endpoint is the change in Hemoglobin A1c [ Time Frame: From baseline through Week 52 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00968812 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 28, 2009) | The percent change in body weight [ Time Frame: From baseline through Week 52 ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride |
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Official Title ICMJE | A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy |
Brief Summary | The purpose of this study is to demonstrate the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with type 2 diabetes. |
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, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of JNJ-28431754 (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Diabetes Mellitus, Type 2 |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1281 | ||||
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Estimated Completion Date | January 2013 | ||||
Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Brazil, Canada, Costa Rica, Denmark, Finland, Germany, India, Israel, Korea, Republic of, Mexico, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Ukraine |
Administrative Information
NCT ID ICMJE | NCT00968812 | ||||
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Responsible Party | Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | ||||
Study ID Numbers ICMJE | CR016480 | ||||
Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |