CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride


Tracking Information

Start Date  ICMJEAugust 2009
Estimated Primary Completion DateJanuary 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 ICMJESame as current
Change HistoryComplete 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 ICMJESame as current

Descriptive Information

Brief Title  ICMJECANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Official Title  ICMJEA 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: glimepiride
    starting dosage of 1mg increased to max of 6 or 8 mg once daily for 104 weeks
  • Drug: JNJ-28431754
    100 or 300 mg once daily for 104 weeks
Study Arms / Comparison Groups
  • 001: Active Comparator
    glimepiride starting dosage of 1mg increased to max of 6 or 8 mg once daily for 104 weeks
    Intervention: Drug: glimepiride
  • 002: Experimental
    JNJ-28431754 100 or 300 mg once daily for 104 weeks
    Intervention: Drug: JNJ-28431754

Recruitment Information

Estimated Enrollment  ICMJE1281
Estimated Completion DateJanuary 2013
Estimated Primary Completion DateJanuary 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
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
Location Countries  ICMJEUnited 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  ICMJENCT00968812
Responsible PartyClinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Study ID Numbers  ICMJECR016480
Study Sponsor  ICMJEJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical TrialJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information Provided ByJohnson & Johnson Pharmaceutical Research & Development, L.L.C.