An Efficacy, Safety and Tolerability Study of Canagliflozin in Patients with Type 2 Diabetes Mellitus With Potential Cardiovascular Risk Factors

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 CANVAS Trial: CANagliflozin CardioVascular Assessment Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012140-16-GB

Enrollment

4500

Registered

2009-10-14

Start date

2010-01-06

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus and history or high risk cardiovascular disease MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861 MedDRA version: 19.0 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849

Interventions

Trade Name: Invokana Product Name: Canagliflozin Product Code: JNJ-28431754 Pharmaceutical Form: Capsule INN or Proposed INN: Canagliflo

Eligibility

Sex/Gender

All

Inclusion criteria

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 Full details are included within the CANVAS study protocol. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1350

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to assess the effect of canagliflozin (JNJ- 28431754) on cardiovascular (CV) risk when used in the treatment of patients with type 2 diabetes mellitus (T2DM). Other objectives include evaluating the effectiveness of canagliflozin. ;Secondary Objective: To assess effects on beta-cell function, progression of albuminuria, renal function and glycemic efficacy.;Primary end point(s): Time to first occurrence of a major adverse cardiovascular event (including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke);Timepoint(s) of evaluation of this end point: Baseline, time to event (up to April 2017)	—

Measure

Time frame

Main Objective: The purpose of this study is to assess the effect of canagliflozin (JNJ- 28431754) on cardiovascular (CV) risk when used in the treatment of patients with type 2 diabetes mellitus (T2DM). Other objectives include evaluating the effectiveness of canagliflozin. ;Secondary Objective: To assess effects on beta-cell function, progression of albuminuria, renal function and glycemic efficacy.;Primary end point(s): Time to first occurrence of a major adverse cardiovascular event (including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke);Timepoint(s) of evaluation of this end point: Baseline, time to event (up to April 2017)

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Change from Baseline in homeostasis model assessment (HOMA) 2) Percentage of patients with progression of albuminuria 3) Change in glycosylated hemoglobin (HbA1c) from Baseline to Week 18 ; Timepoint(s) of evaluation of this end point: 1 and 2) Baseline, up to end of treatment (up to April 2017) 3) Day 1 (Baseline) to Week 18	—

Countries

Argentina, Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Russian Federation, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

Public ContactClinical Registry Group

Janssen Research & Development

ClinicalTrialsEU@its.jnj.com+31 (0)71 524 21 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026