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CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., January 2010
First Received: August 28, 2009   Last Updated: January 29, 2010   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00968812
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: glimepiride
Drug: JNJ-28431754
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The primary efficacy endpoint is the change in Hemoglobin A1c [ Time Frame: From baseline through Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percent change in body weight [ Time Frame: From baseline through Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1281
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
001: Active Comparator
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
002: Experimental
JNJ-28431754 100 or 300 mg once daily for 104 weeks
Drug: JNJ-28431754
100 or 300 mg once daily for 104 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968812

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

  Show 148 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Clinical Leader )
Study ID Numbers: CR016480
Study First Received: August 28, 2009
Last Updated: January 29, 2010
ClinicalTrials.gov Identifier: NCT00968812     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Diabetes
Metformin
Glimepiride
Hemoglobin A1c
Type 2 diabetes mellitus
Canagliflozin

Additional relevant MeSH terms:
Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 04, 2010