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| Sponsor: | Janssen Research & Development, LLC |
|---|---|
| Information provided by: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT00968812 |
Purpose
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of JNJ-28431754 (canagliflozin) compared with glimepiride in patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Glimepiride Drug: JNJ-28431754 (canagliflozin) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 1455 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 001
glimepiride starting dosage of 1mg increased to max of 6 or 8 mg once daily for 104 weeks
|
Drug: Glimepiride
starting dosage of 1mg increased to max of 6 or 8 mg once daily for 104 weeks
Other Name: sulfonylurea
|
|
Experimental: 002
JNJ-28431754 100 or 300 mg once daily for 104 weeks
|
Drug: JNJ-28431754 (canagliflozin)
100 or 300 mg once daily for 104 weeks
|
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 (canagliflozin) compared with a sulfonylurea (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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 137 Study Locations| Study Director: | Janssen Research & Development, LLC C. Clinical Trial | Janssen Research & Development, LLC |
More Information
| Responsible Party: | Clinical Leader, Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT00968812 History of Changes |
| Other Study ID Numbers: | CR016480, 28431754DIA3009 |
| Study First Received: | August 28, 2009 |
| Last Updated: | May 16, 2012 |
| Health Authority: | United States: Food and Drug Administration Ukraine: State Pharmacological Center - Ministry of Health |
|
Diabetes Metformin Glimepiride |
Hemoglobin A1c Type 2 diabetes mellitus Canagliflozin |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Metformin Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |