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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: April 18, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Risk Factors
Drug: Canagliflozin (JNJ-28431754)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Major adverse cardiovascular events, including CV death, nonfatal myocardial infarction (MI), and nonfatal stroke [ Time Frame: Baseline, time to event (up to April 2017) ]

Secondary Outcome Measures:
  • A standard measure of fasting insulin secretion [ Time Frame: Baseline, up to end of treatment (up to April 2017) ]
  • Progression of albumin in the urine [ Time Frame: Baseline, up to end of treatment (up to April 2017) ]
  • 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 ]

Enrollment: 4330
Actual Study Start Date: December 9, 2009
Study Completion Date: February 22, 2017
Primary Completion Date: February 22, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
One placebo capsule taken orally (by mouth) once daily
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
Drug: Canagliflozin (JNJ-28431754)
One 100 mg or 300 mg capsule taken orally (by mouth) once daily
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
Drug: Canagliflozin (JNJ-28431754)
One 100 mg or 300 mg capsule taken orally (by mouth) once daily

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. 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, and is projected to occur prior to April 2017.
  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032629

  Show 313 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
The George Institute for Global Health, Australia
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01032629     History of Changes
Other Study ID Numbers: CR016627
28431754DIA3008 ( Other Identifier: Janssen Research & Development, LLC )
2009-012140-16 ( EudraCT Number )
Study First Received: December 10, 2009
Last Updated: April 18, 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Janssen Research & Development, LLC:
Diabetes
Type 2 diabetes mellitus
Cardiovascular risk
Cardiovascular outcomes
Canagliflozin (JNJ-28431754)
Placebo

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017