CANVAS - CANagliflozin cardioVascular Assessment Study 


Tracking Information

Start Date  ICMJENovember 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2009)		Major adverse cardiovascular events, including CV death, nonfatal MI, and nonfatal stroke [ Time Frame: Time to event (approximately 4 years) ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01032629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 14, 2009)
  • a standard measure of fasting insulin secretion [ Time Frame: end of treatment (approximately 4 years) ] [ Designated as safety issue: No ]
  • progression of albumin in the urine [ Time Frame: end of treatment (approximately 4 years) ] [ Designated as safety issue: Yes ]
  • effectiveness of lowering blood glucose (in substudies of patients who are also taking specific commonly-used diabetes agents) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJECANVAS - CANagliflozin cardioVascular Assessment Study
Official Title  ICMJEA Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus
Brief Summary

The study will assess canagliflozin in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events. Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

Detailed Description

The study will evaluate canagliflozin compared to placebo on CV events including CV death, heart attack, and stroke in patients with T2DM, whose diabetes is not well controlled at the beginning of the study and who have a history of CV events or have a high risk for CV events. The study includes 3 substudies which will compare the effectiveness of lowering blood glucose and assess the safety of canagliflozin relative to placebo in patients receiving specific commonly-used diabetes agents. The patients will receive capsules of canagliflozin (either 100 or 300 mg), or matching placebo, taken by mouth, with study duration for individual patients of up to 4 years or longer (additional patients may be recruited and/or a longer study duration planned based on an analysis and recommendation by an independent data monitoring committee).

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
  • Risk Factors
Intervention  ICMJE
  • Drug: Canagliflozin on background standard of care for diabetes
    100 or 300 mg once daily for up to 4 years or longer for individual patients
  • Drug: Placebo on background standard of care for diabetes
    once daily for up to 4 years or longer for individual patients
Study Arms / Comparison Groups
  • 001: Placebo Comparator
    Placebo on background standard of care for diabetes once daily for up to 4 years or longer for individual patients
    Intervention: Drug: Placebo on background standard of care for diabetes
  • 002: Experimental
    Canagliflozin on background standard of care for diabetes 100 or 300 mg once daily for up to 4 years or longer for individual patients
    Intervention: Drug: Canagliflozin on background standard of care for diabetes

Recruitment Information

Estimated Enrollment  ICMJE4500
Estimated Completion DateApril 2013
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have a diagnosis of T2DM and a history of or a high risk for CV disease
  • Patients must have inadequate diabetes control (as defined by HbA1c greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs

Exclusion Criteria:

  • A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening
GenderBoth
Ages30 Years and older
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,   Canada,   Czech Republic,   Estonia,   Germany,   Hungary,   Mexico,   Netherlands,   Poland,   Russian Federation,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT01032629
Responsible PartyClinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Study ID Numbers  ICMJECR016627, CR016627
Study Sponsor  ICMJEJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJEGeorge Institute, Sydney, Australia
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.