CANVAS - CANagliflozin cardioVascular Assessment Study

This study is ongoing, but not recruiting participants.
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: September 12, 2014
Last verified: September 2014

December 10, 2009
September 12, 2014
December 2009
April 2017   (final data collection date for primary outcome measure)
Major adverse cardiovascular events, including CV death, nonfatal myocardial infarction (MI), and nonfatal stroke [ Time Frame: Baseline, time to event (up to April 2017) ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT01032629 on ClinicalTrials.gov Archive Site
  • A standard measure of fasting insulin secretion [ Time Frame: Baseline, up to end of treatment (up to April 2017) ] [ Designated as safety issue: No ]
  • Progression of albumin in the urine [ Time Frame: Baseline, up to end of treatment (up to April 2017) ] [ 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: Baseline, up to Week 18 ] [ Designated as safety issue: No ]
  • 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 ]
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 meta-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, and is projected to occur prior to April 2017.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Cardiovascular Diseases
  • Risk Factors
  • Drug: Canagliflozin (JNJ-28431754)
    One 100 mg or 300 mg capsule taken orally (by mouth) once daily
  • Drug: Placebo
    One placebo 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)
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4330
June 2018
April 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a diagnosis of type 2 diabetes mellitus and a history of, or a high risk for, cardiovascular disease
  • 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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States,   Argentina,   United Kingdom,   Belgium,   Canada,   Colombia,   Czech Republic,   Estonia,   France,   Germany,   Hungary,   India,   Israel,   Luxembourg,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Ukraine
 
NCT01032629
CR016627, 28431754DIA3008, 2009-012140-16
Yes
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
September 2014

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