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CANVAS - CANagliflozin cardioVascular Assessment Study (CANVAS)

This study has been completed.
Sponsor:
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01032629
First received: December 10, 2009
Last updated: July 10, 2017
Last verified: July 2017
History of Changes
December 10, 2009
July 10, 2017
December 9, 2009
February 22, 2017   (Final data collection date for primary outcome measure)
Time to First Occurrence of Major Adverse Cardiovascular Events, Including CV Death, Nonfatal Myocardial Infarction (MI), and Nonfatal Stroke [ Time Frame: Baseline, time to event up to end of study (approximately 8 years) ]
Major adverse cardiovascular events, including CV death, nonfatal MI, and nonfatal stroke [ Time Frame: Time to event (approximately 4 years) ]
Complete list of historical versions of study NCT01032629 on ClinicalTrials.gov Archive Site
  • A Standard Masure of Fasting Insulin Secretion [ Time Frame: Baseline up to end of study (approximately 8 years) ]
  • Time to First Occurrence of Progression of Albumin in the Urine [ Time Frame: Baseline, time to event up to end of study (approximately 8 years) ]
  • Change in Urinary Albumin/Creatinine Ratio From Baseline at End of Treatment [ Time Frame: Baseline, end of treatment (approximately 369 weeks) ]
  • Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at End of Treatment [ Time Frame: Baseline, end of treatment (approximately 369 weeks) ]
  • Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
  • Change in Fasting Plasma Glucose (FPG) From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
  • Change in Body Weight From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
  • Change in Systolic Blood Pressure From Baseline at Week 18and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
  • Change in Diastolic Blood Pressure From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
  • Percent Change in Fasting Plasma Lipid Levels From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
    Fasting plasma lipids included triglycerides, high-density lipoprotein-cholesterol [HDL-C], low-density lipoprotein-cholesterol [LDL-C], and total cholesterol.
  • Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio From Baseline at Week 18 and End of Treatment [ Time Frame: Baseline, Week 18, and end of treatment (approximately 369 weeks) ]
  • Effectiveness of Lowering Blood Glucose (in Substudies of Patients who are Also Taking Specific Commonly-Used Diabetes Agents) [ Time Frame: Baseline up to Week 18 ]
  • A standard measure of fasting insulin secretion [ Time Frame: end of treatment (approximately 4 years) ]
  • Progression of albumin in the urine [ Time Frame: end of treatment (approximately 4 years) ]
  • Effectiveness of Lowering Blood Glucose (in Substudies of Patients who are Also Taking Specific Commonly-Used Diabetes Agents) [ Time Frame: 18 weeks ]
Not Provided
Not Provided
 
CANVAS - CANagliflozin cardioVascular Assessment Study
A 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

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.
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. 4,330 participants will be randomly assigned to treatment with 1 of 2 doses of canagliflozin (100 or 300 mg) or placebo, in a 1:1:1 ratio. This study was originally designed to last for up to 9 years. As per FDA post-marketing requirements for canagliflozin, the study's last subject last visit will now occur when enough MACE events (ie, CV death, nonfatal myocardial infarction, nonfatal stroke) are accumulated between the CANVAS (this study) and CANVAS-R studies. The completion target was reached in February 2017.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
  • Risk Factors
  • Drug: Placebo
    One placebo capsule taken orally (by mouth) once daily
  • Drug: Canagliflozin (JNJ-28431754) 100 mg
    One 100 mg capsule taken orally (by mouth) once daily
  • Drug: Canagliflozin (JNJ-28431754) 300 mg
    One 300 mg capsule taken orally (by mouth) once daily
  • Placebo Comparator: Placebo
    Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study
    Intervention: Drug: Placebo
  • Experimental: Canagliflozin (JNJ-28431754) 100 mg
    Each patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study
    Intervention: Drug: Canagliflozin (JNJ-28431754) 100 mg
  • Experimental: Canagliflozin (JNJ-28431754) 300 mg
    Each patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study
    Intervention: Drug: Canagliflozin (JNJ-28431754) 300 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4330
February 22, 2017
February 22, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
  • Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin 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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Canada,   Colombia,   Czechia,   Estonia,   France,   Germany,   Hungary,   India,   Israel,   Luxembourg,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom,   United States
Brazil,   Czech Republic
 
NCT01032629
CR016627
28431754DIA3008 ( Other Identifier: Janssen Research & Development, LLC )
2009-012140-16 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Research & Development, LLC
Janssen Research & Development, LLC
The George Institute for Global Health, Australia
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP