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CANVAS - CANagliflozin cardioVascular Assessment Study (CANVAS)

Primary Purpose

Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Factors

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Canagliflozin (JNJ-28431754) 100 mg
Canagliflozin (JNJ-28431754) 300 mg
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Type 2 diabetes mellitus, Cardiovascular risk, Cardiovascular outcomes, Canagliflozin (JNJ-28431754), Placebo

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Canagliflozin (JNJ-28431754) 100 mg

Canagliflozin (JNJ-28431754) 300 mg

Arm Description

Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study

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

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

Outcomes

Primary Outcome Measures

Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.

Secondary Outcome Measures

Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent.
Percentage of Participants With Progression of Albuminuria at the End-of-Treatment
Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to [>=] 30 milligram per gram (mg/g) and less than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed.
Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment
A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.
Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment
Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment
Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m^2) = 175 * (serum creatinine) ^ 1.154 * (Age) ^-0.203 *(0.742 if female) * (1.21 if Black).
Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment
Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood.
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment
Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed.
Percent Change From Baseline in Body Weight at End-of-Treatment
Percent change from baseline in body weight was assessed at the end of treatment.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment
Change from baseline in systolic blood pressure and diastolic blood pressure was assessed.
Change From Baseline in Triglycerides Levels at End-of-Treatment
Change from baseline in triglycerides levels was assessed.
Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment
Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed.
Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment
Change from baseline in LDL-C to HDL-C ratio was assessed.

Full Information

First Posted
December 10, 2009
Last Updated
November 5, 2018
Sponsor
Janssen Research & Development, LLC
Collaborators
The George Institute for Global Health, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01032629
Brief Title
CANVAS - CANagliflozin cardioVascular Assessment Study
Acronym
CANVAS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 9, 2009 (Actual)
Primary Completion Date
February 22, 2017 (Actual)
Study Completion Date
February 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
The George Institute for Global Health, Australia

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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. The completion target was reached in February 2017.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Factors
Keywords
Diabetes, Type 2 diabetes mellitus, Cardiovascular risk, Cardiovascular outcomes, Canagliflozin (JNJ-28431754), Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study
Arm Title
Canagliflozin (JNJ-28431754) 100 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Canagliflozin (JNJ-28431754) 300 mg
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo capsule taken orally (by mouth) once daily
Intervention Type
Drug
Intervention Name(s)
Canagliflozin (JNJ-28431754) 100 mg
Intervention Description
One 100 mg capsule taken orally (by mouth) once daily
Intervention Type
Drug
Intervention Name(s)
Canagliflozin (JNJ-28431754) 300 mg
Intervention Description
One 300 mg capsule taken orally (by mouth) once daily
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
Description
MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
Time Frame
Up to approximately 8 years
Secondary Outcome Measure Information:
Title
Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)
Description
The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Percentage of Participants With Progression of Albuminuria at the End-of-Treatment
Description
Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to [>=] 30 milligram per gram (mg/g) and less than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed.
Time Frame
End of treatment (approximately 338 weeks)
Title
Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment
Description
A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment
Description
Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine.
Time Frame
Baseline and End of treatment (approximately 338 weeks)
Title
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment
Description
Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m^2) = 175 * (serum creatinine) ^ 1.154 * (Age) ^-0.203 *(0.742 if female) * (1.21 if Black).
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment
Description
Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment
Description
Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Percent Change From Baseline in Body Weight at End-of-Treatment
Description
Percent change from baseline in body weight was assessed at the end of treatment.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment
Description
Change from baseline in systolic blood pressure and diastolic blood pressure was assessed.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Change From Baseline in Triglycerides Levels at End-of-Treatment
Description
Change from baseline in triglycerides levels was assessed.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment
Description
Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed.
Time Frame
Baseline and end of treatment (approximately 338 weeks)
Title
Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment
Description
Change from baseline in LDL-C to HDL-C ratio was assessed.
Time Frame
Baseline and end of treatment (approximately 338 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Birmingham
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Alabama
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United States
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Mesa
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Arizona
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United States
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Tucson
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Arizona
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La Mesa
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California
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Los Gatos
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Pismo Beach
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Stockton
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Walnut Creek
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Doral
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Fort Lauderdale
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Jacksonville
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Miami
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Plantation
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Atlanta
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Georgia
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Duluth
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Georgia
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Boise
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Idaho
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Eagle
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Meridian
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Peoria
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Illinois
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Topeka
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Kansas
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Crestview Hills
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Kentucky
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Lexington
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Kentucky
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Auburn
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Maine
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Scarborough
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Maine
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Oxon Hill
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Maryland
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Royal Oak
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Michigan
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Kansas City
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Missouri
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Saint Louis
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Missouri
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Omaha
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Nebraska
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Camden
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New Jersey
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Bronx
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New York
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Flushing
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New York
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Chapel Hill
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North Carolina
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Charlotte
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North Carolina
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Cincinnati
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Ohio
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Cleveland
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Ohio
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Columbus
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Ohio
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Gallipolis
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Ohio
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Mentor
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Ohio
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Toledo
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Ohio
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Beaver
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Pennsylvania
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Norristown
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Sayre
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Greenville
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South Carolina
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Kingsport
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Tennessee
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Dallas
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Texas
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Houston
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Odessa
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Texas
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San Antonio
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Temple
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Draper
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Utah
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Salt Lake City
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Utah
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Sandy
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Utah
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West Jordan
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Utah
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Danville
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Virginia
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Richmond
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Virginia
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Spokane
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Washington
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Tacoma
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Washington
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United States
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Buenos Aires
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Argentina
City
Capital Federal
Country
Argentina
City
Ciudad Autonma Buenos Aires
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Argentina
City
Ciudad Autonoma De Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
Corrientes
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Argentina
City
Godoy Cruz
Country
Argentina
City
Mar Del Plata
Country
Argentina
City
Rosario
Country
Argentina
City
Santa Fe
Country
Argentina
City
Auchenflower
Country
Australia
City
Box Hill
Country
Australia
City
Caboolture
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Australia
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Caringbah
Country
Australia
City
Clayton
Country
Australia
City
Daw Park
Country
Australia
City
East Ringwood
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Australia
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Elizabeth Vale
Country
Australia
City
Hornsby, Nsw 2077
Country
Australia
City
Kippa Ring
Country
Australia
City
Launceston
Country
Australia
City
Liverpool
Country
Australia
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Melbourne
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Australia
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Milton
Country
Australia
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Parkville
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Australia
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Reservoir
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Australia
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Sherwood
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Australia
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Southport
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Australia
City
St Leonards
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Australia
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West Heidelberg
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Australia
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Wollongong
Country
Australia
City
Woolloongabba
Country
Australia
City
Arlon
Country
Belgium
City
Bonheiden
Country
Belgium
City
Brussel
Country
Belgium
City
Edegem
Country
Belgium
City
Genk
Country
Belgium
City
Leuven
Country
Belgium
City
Calgary
State/Province
Alberta
Country
Canada
City
Coquitlam
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
St. John'S
State/Province
Newfoundland and Labrador
Country
Canada
City
Brampton
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Mississauga
State/Province
Ontario
Country
Canada
City
Nemarket
State/Province
Ontario
Country
Canada
City
Sarnia
State/Province
Ontario
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Canada
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Sudbury
State/Province
Ontario
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Canada
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Toronto
State/Province
Ontario
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Canada
City
Laval
State/Province
Quebec
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Canada
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Lévis
State/Province
Quebec
Country
Canada
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Montreal
State/Province
Quebec
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Canada
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Val-Belair
State/Province
Quebec
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Canada
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Saskatoon
State/Province
Saskatchewan
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Canada
City
Bogota
Country
Colombia
City
Floridablanca
Country
Colombia
City
Kralupy Nad Vltavou
Country
Czechia
City
Moravsky Krumlov
Country
Czechia
City
Olomouc 9
Country
Czechia
City
Ostrava
Country
Czechia
City
Pisek
Country
Czechia
City
Prague 5
Country
Czechia
City
Praha 11
Country
Czechia
City
Praha 8
Country
Czechia
City
Praha
Country
Czechia
City
Znojmo N/A
Country
Czechia
City
Pärnu
Country
Estonia
City
Tallinn
Country
Estonia
City
Tartu
Country
Estonia
City
Viljandi
Country
Estonia
City
Amiens
Country
France
City
Nimes Cedex 9
Country
France
City
Pessac
Country
France
City
Berlin
Country
Germany
City
Dortmund
Country
Germany
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Dresden
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Germany
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Hamburg
Country
Germany
City
Künzing
Country
Germany
City
Mainz
Country
Germany
City
Münster
Country
Germany
City
Pirna
Country
Germany
City
Saarlouis
Country
Germany
City
Speyer
Country
Germany
City
Villingen-Schwenningen
Country
Germany
City
Budapest
Country
Hungary
City
Kecskemet
Country
Hungary
City
Mosonmagyaróvár
Country
Hungary
City
Zalaegerszeg
Country
Hungary
City
Ahemadabad
Country
India
City
Ahmedabad
Country
India
City
Ambawadi
Country
India
City
Bangalore, Karnataka
Country
India
City
Bangalore
Country
India
City
Belgaum
Country
India
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Calicut
Country
India
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Chennai
Country
India
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Cochin
Country
India
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Coimbatore
Country
India
City
Ernakulam
Country
India
City
Ghaziabad
Country
India
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Hyderabad
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India
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Indore
Country
India
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Jaipur
Country
India
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Karnal
Country
India
City
Kerala
Country
India
City
Kochi
Country
India
City
Kolkata
Country
India
City
Lucknow
Country
India
City
Mangalore
Country
India
City
Mumbai
Country
India
City
Mysore
Country
India
City
Nagpur
Country
India
City
New Delhi
Country
India
City
Patna
Country
India
City
Pune
Country
India
City
Rajkot
Country
India
City
Trivandrum, Kerala
Country
India
City
Vadodhara
Country
India
City
Vijayawada
Country
India
City
Visakhapatnam
Country
India
City
Beer Sheba
Country
Israel
City
Holon
Country
Israel
City
Jerusalem
Country
Israel
City
Kfar Saba
Country
Israel
City
Luxembourg
Country
Luxembourg
City
Georgetown
Country
Malaysia
City
Johor Bahru
Country
Malaysia
City
Kota Bharu
Country
Malaysia
City
Kuala Lumpur N/A
Country
Malaysia
City
Petaling Jaya
Country
Malaysia
City
Pulau Pinang
Country
Malaysia
City
Subang Jaya
Country
Malaysia
City
Aguascalientes
Country
Mexico
City
Celaya
Country
Mexico
City
Ciudad De Mexico
Country
Mexico
City
Durango
Country
Mexico
City
Guadalajara
Country
Mexico
City
Monterrey
Country
Mexico
City
Almelo
Country
Netherlands
City
Almere
Country
Netherlands
City
Amsterdam
Country
Netherlands
City
Arnhem
Country
Netherlands
City
Delft
Country
Netherlands
City
Den Helder
Country
Netherlands
City
Dordrecht
Country
Netherlands
City
Eindhoven
Country
Netherlands
City
Groningen
Country
Netherlands
City
Hoorn Nh
Country
Netherlands
City
Rotterdam
Country
Netherlands
City
Tilburg
Country
Netherlands
City
Utrecht
Country
Netherlands
City
Velp Gld
Country
Netherlands
City
Zoetermeer
Country
Netherlands
City
Zwijndrecht
Country
Netherlands
City
Auckland
Country
New Zealand
City
Christchurch
Country
New Zealand
City
Dunedin
Country
New Zealand
City
Tauranga
Country
New Zealand
City
Wellington
Country
New Zealand
City
Alesund
Country
Norway
City
Asker
Country
Norway
City
Bekkestua
Country
Norway
City
Elverum
Country
Norway
City
Hamar
Country
Norway
City
Lierskogen
Country
Norway
City
Moss
Country
Norway
City
Oslo
Country
Norway
City
Skedsmokorset
Country
Norway
City
Bialystok
Country
Poland
City
Ciechocinek
Country
Poland
City
Gniewkowo
Country
Poland
City
Grudziadz
Country
Poland
City
Katowice
Country
Poland
City
Krakow
Country
Poland
City
Lublin
Country
Poland
City
Plock
Country
Poland
City
Poznan
Country
Poland
City
Rzeszow
Country
Poland
City
Slawkow
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Arkhangelsk
Country
Russian Federation
City
Chelyabinsk
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Kirov
Country
Russian Federation
City
Kursk
Country
Russian Federation
City
Moscow N/A
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhny Novgorod
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Omsk
Country
Russian Federation
City
Penza
Country
Russian Federation
City
Rostov-On-Don
Country
Russian Federation
City
Russia
Country
Russian Federation
City
Ryazan
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
Smolensk
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Tomsk
Country
Russian Federation
City
Tula
Country
Russian Federation
City
Tyumen
Country
Russian Federation
City
Yaroslavl Nap
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Alicante
Country
Spain
City
Almeria
Country
Spain
City
Barcelona
Country
Spain
City
Figueres
Country
Spain
City
Madrid
Country
Spain
City
Málaga
Country
Spain
City
Oviedo
Country
Spain
City
Reus
Country
Spain
City
Sabadell
Country
Spain
City
San Juan De Alicante
Country
Spain
City
Santiago De Compostela
Country
Spain
City
Sevilla N/A
Country
Spain
City
Valencia
Country
Spain
City
Viladecans
Country
Spain
City
Borås
Country
Sweden
City
Göteborg
Country
Sweden
City
Helsingborg
Country
Sweden
City
Lund
Country
Sweden
City
Malmö
Country
Sweden
City
Oskarshamn N/A
Country
Sweden
City
Piteå
Country
Sweden
City
Stockholm
Country
Sweden
City
Uddevalla
Country
Sweden
City
Dnepropetrovsk
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Kharkov
Country
Ukraine
City
Kiev
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Odessa
Country
Ukraine
City
Ternopol
Country
Ukraine
City
Uzhgorod
Country
Ukraine
City
Vinnitsa
Country
Ukraine
City
Zaporozhye
Country
Ukraine
City
Belfast
Country
United Kingdom
City
Blackburn
Country
United Kingdom
City
Bolton
Country
United Kingdom
City
Chorley
Country
United Kingdom
City
Derby
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
Hull
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Londonderry
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Randalstown
Country
United Kingdom
City
Salford
Country
United Kingdom
City
York
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35724306
Citation
Ferrannini E, Baldi S, Scozzaro T, Tsimihodimos V, Tesfaye F, Shaw W, Rosenthal N, Figtree GA, Neal B, Mahaffey KW, Perkovic V, Hansen MK. Fasting Substrate Concentrations Predict Cardiovascular Outcomes in the CANagliflozin cardioVascular Assessment Study (CANVAS). Diabetes Care. 2022 Aug 1;45(8):1893-1899. doi: 10.2337/dc21-2398.
Results Reference
derived
PubMed Identifier
35115099
Citation
Vaduganathan M, Sattar N, Xu J, Butler J, Mahaffey KW, Neal B, Shaw W, Rosenthal N, Pfeifer M, Hansen MK, Januzzi JL Jr. Stress Cardiac Biomarkers, Cardiovascular and Renal Outcomes, and Response to Canagliflozin. J Am Coll Cardiol. 2022 Feb 8;79(5):432-444. doi: 10.1016/j.jacc.2021.11.027.
Results Reference
derived
PubMed Identifier
34876454
Citation
Waijer SW, Sen T, Arnott C, Neal B, Kosterink JGW, Mahaffey KW, Parikh CR, de Zeeuw D, Perkovic V, Neuen BL, Coca SG, Hansen MK, Gansevoort RT, Heerspink HJL. Association between TNF Receptors and KIM-1 with Kidney Outcomes in Early-Stage Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2022 Feb;17(2):251-259. doi: 10.2215/CJN.08780621. Epub 2021 Dec 7.
Results Reference
derived
PubMed Identifier
34448033
Citation
Young TK, Li JW, Kang A, Heerspink HJL, Hockham C, Arnott C, Neuen BL, Zoungas S, Mahaffey KW, Perkovic V, de Zeeuw D, Fulcher G, Neal B, Jardine M. Effects of canagliflozin compared with placebo on major adverse cardiovascular and kidney events in patient groups with different baseline levels of HbA1c, disease duration and treatment intensity: results from the CANVAS Program. Diabetologia. 2021 Nov;64(11):2402-2414. doi: 10.1007/s00125-021-05524-1. Epub 2021 Aug 26.
Results Reference
derived
PubMed Identifier
33826709
Citation
Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.
Results Reference
derived
PubMed Identifier
33595905
Citation
Yu J, Arnott C, Neuen BL, Heersprink HL, Mahaffey KW, Cannon CP, Khan SS, Baldridge AS, Shah SJ, Huang Y, Li C, Figtree GA, Perkovic V, Jardine MJ, Neal B, Huffman MD. Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program. ESC Heart Fail. 2021 Apr;8(2):1482-1493. doi: 10.1002/ehf2.13236. Epub 2021 Feb 17. Erratum In: ESC Heart Fail. 2021 May 3;:
Results Reference
derived
PubMed Identifier
33158949
Citation
Januzzi JL Jr, Butler J, Sattar N, Xu J, Shaw W, Rosenthal N, Pfeifer M, Mahaffey KW, Neal B, Hansen MK. Insulin-Like Growth Factor Binding Protein 7 Predicts Renal and Cardiovascular Outcomes in the Canagliflozin Cardiovascular Assessment Study. Diabetes Care. 2021 Jan;44(1):210-216. doi: 10.2337/dc20-1889. Epub 2020 Nov 6.
Results Reference
derived
PubMed Identifier
33121714
Citation
Januzzi JL Jr, Xu J, Li J, Shaw W, Oh R, Pfeifer M, Butler J, Sattar N, Mahaffey KW, Neal B, Hansen MK. Effects of Canagliflozin on Amino-Terminal Pro-B-Type Natriuretic Peptide: Implications for Cardiovascular Risk Reduction. J Am Coll Cardiol. 2020 Nov 3;76(18):2076-2085. doi: 10.1016/j.jacc.2020.09.004.
Results Reference
derived
PubMed Identifier
32971190
Citation
Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Blais J, Li Q, Jardine MJ, Perkovic V, Wheeler DC. Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program. Am J Kidney Dis. 2021 Jan;77(1):23-34.e1. doi: 10.1053/j.ajkd.2020.06.018. Epub 2020 Sep 21.
Results Reference
derived
PubMed Identifier
32694216
Citation
Oshima M, Neal B, Toyama T, Ohkuma T, Li Q, de Zeeuw D, Heerspink HJL, Mahaffey KW, Fulcher G, Canovatchel W, Matthews DR, Perkovic V. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program. J Am Soc Nephrol. 2020 Oct;31(10):2446-2456. doi: 10.1681/ASN.2019121312. Epub 2020 Jul 21.
Results Reference
derived
PubMed Identifier
32691499
Citation
Matthews DR, Wysham C, Davies M, Slee A, Alba M, Lee M, Perkovic V, Mahaffey KW, Neal B. Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program. Diabetes Obes Metab. 2020 Nov;22(11):2199-2203. doi: 10.1111/dom.14143. Epub 2020 Aug 24.
Results Reference
derived
PubMed Identifier
31399845
Citation
Zhou Z, Jardine M, Perkovic V, Matthews DR, Mahaffey KW, de Zeeuw D, Fulcher G, Desai M, Oh R, Simpson R, Watts NB, Neal B. Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program. Diabetologia. 2019 Oct;62(10):1854-1867. doi: 10.1007/s00125-019-4955-5. Epub 2019 Aug 10.
Results Reference
derived
PubMed Identifier
30882240
Citation
Figtree GA, Radholm K, Barrett TD, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Neal B. Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2591-2593. doi: 10.1161/CIRCULATIONAHA.119.040057. Epub 2019 Mar 17. No abstract available.
Results Reference
derived
PubMed Identifier
30591006
Citation
Zhou Z, Lindley RI, Radholm K, Jenkins B, Watson J, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Shaw W, Oh R, Desai M, Matthews DR, Neal B. Canagliflozin and Stroke in Type 2 Diabetes Mellitus. Stroke. 2019 Feb;50(2):396-404. doi: 10.1161/STROKEAHA.118.023009.
Results Reference
derived
PubMed Identifier
29941478
Citation
Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Desai M, Li Q, Deng H, Rosenthal N, Jardine MJ, Bakris G, Perkovic V. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation. 2018 Oct 9;138(15):1537-1550. doi: 10.1161/CIRCULATIONAHA.118.035901.
Results Reference
derived
PubMed Identifier
29937267
Citation
Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21.
Results Reference
derived
PubMed Identifier
29693360
Citation
Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.
Results Reference
derived
PubMed Identifier
29526832
Citation
Radholm K, Figtree G, Perkovic V, Solomon SD, Mahaffey KW, de Zeeuw D, Fulcher G, Barrett TD, Shaw W, Desai M, Matthews DR, Neal B. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation. 2018 Jul 31;138(5):458-468. doi: 10.1161/CIRCULATIONAHA.118.034222.
Results Reference
derived
PubMed Identifier
29133604
Citation
Mahaffey KW, Neal B, Perkovic V, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Fabbrini E, Sun T, Li Q, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018 Jan 23;137(4):323-334. doi: 10.1161/CIRCULATIONAHA.117.032038. Epub 2017 Nov 13.
Results Reference
derived
PubMed Identifier
29103664
Citation
Yale JF, Xie J, Sherman SE, Garceau C. Canagliflozin in Conjunction With Sulfonylurea Maintains Glycemic Control and Weight Loss Over 52 Weeks: A Randomized, Controlled Trial in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2017 Nov;39(11):2230-2242.e2. doi: 10.1016/j.clinthera.2017.10.003. Epub 2017 Nov 3.
Results Reference
derived
PubMed Identifier
28605608
Citation
Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.
Results Reference
derived
PubMed Identifier
26580237
Citation
Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.
Results Reference
derived
PubMed Identifier
26121561
Citation
Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.
Results Reference
derived
PubMed Identifier
26081793
Citation
Fulcher G, Matthews DR, Perkovic V, de Zeeuw D, Mahaffey KW, Weiss R, Rosenstock J, Capuano G, Desai M, Shaw W, Vercruysse F, Meininger G, Neal B. Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial. Diabetes Ther. 2015 Sep;6(3):289-302. doi: 10.1007/s13300-015-0117-z. Epub 2015 Jun 17.
Results Reference
derived
PubMed Identifier
25468945
Citation
Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Ways K, Desai M, Shaw W, Capuano G, Alba M, Jiang J, Vercruysse F, Meininger G, Matthews D; CANVAS Trial Collaborative Group. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):403-11. doi: 10.2337/dc14-1237. Epub 2014 Dec 2.
Results Reference
derived
PubMed Identifier
24786834
Citation
Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.
Results Reference
derived
PubMed Identifier
24517339
Citation
Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.
Results Reference
derived
PubMed Identifier
23895803
Citation
Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Stein P, Desai M, Shaw W, Jiang J, Vercruysse F, Meininger G, Matthews D. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial. Am Heart J. 2013 Aug;166(2):217-223.e11. doi: 10.1016/j.ahj.2013.05.007. Epub 2013 Jun 24.
Results Reference
derived

Learn more about this trial

CANVAS - CANagliflozin cardioVascular Assessment Study

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