Phase 3
Completed N=4,330
CANVAS - CANagliflozin cardioVascular Assessment Study
Type 2 Diabetes Mellitus · Cardiovascular Disease · Risk Factors
Source: ClinicalTrials.gov NCT01032629 ↗
Enrolled (actual)
4,330
Serious AEs
41.4%
Results posted
Dec 2018
Primary outcomePrimary: Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke — 30.36; 28.41; 25.37; 26.89 Events per 1000 patient-year — p==0.4576
◆ Published Evidence
Emerging
11citations · ~11 / year
Canagliflozin may increase thromboembolic events in males with erythrocytosis but not in females.
Summary
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.
Linked Publications (5)
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Canagliflozin may increase thromboembolic events in males with erythrocytosis but not in females.
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The Efficacy and Safety of Canagliflozin by Frailty Status in Participants of the CANVAS and CREDENCE Trials.
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Impact of canagliflozin on heart stress and outcomes: Pooled insights from CREDENCE and CANVAS.
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Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial.
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Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke |
30.36; 28.41; 25.37; 26.89 | =0.4576 |
| SECONDARY Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT) |
4.02; 6.82; 8.09 | =0.210 |
| SECONDARY Percentage of Participants With Progression of Albuminuria at the End-of-Treatment |
24.0; 20.2; 18.3 | — |
| SECONDARY Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment |
0.70; 0.67; 1.03 | — |
| SECONDARY Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment |
29.30; 25.50; 24.47 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment |
-5.23; -3.55; -3.98 | — |
| SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment |
0.01; -0.26; -0.31 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment |
0.16; -0.42; -0.57 | — |
| SECONDARY Percent Change From Baseline in Body Weight at End-of-Treatment |
-0.50; -3.47; -4.12 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment |
-1.96; -4.91; -6.49; -2.88; -3.70; -4.51 | — |
| SECONDARY Change From Baseline in Triglycerides Levels at End-of-Treatment |
0.05; 0.13; 0.09 | — |
| SECONDARY Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment |
-0.07; 0.11; 0.16; -0.01; 0.04; 0.05 | — |
| SECONDARY Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment |
-0.04; -0.02; 0.00 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01032629) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.