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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01032629
Registration number
NCT01032629
Ethics application status
Date submitted
10/12/2009
Date registered
15/12/2009
Date last updated
7/12/2018
Titles & IDs
Public title
CANVAS - CANagliflozin cardioVascular Assessment Study
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Scientific 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
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Secondary ID [1]
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28431754DIA3008
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Secondary ID [2]
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CR016627
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Universal Trial Number (UTN)
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Trial acronym
CANVAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Cardiovascular Diseases
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Risk Factors
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Canagliflozin (JNJ-28431754) 100 mg
Treatment: Drugs - Canagliflozin (JNJ-28431754) 300 mg
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
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
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
Treatment: Drugs: Placebo
One placebo capsule taken orally (by mouth) once daily
Treatment: Drugs: Canagliflozin (JNJ-28431754) 100 mg
One 100 mg capsule taken orally (by mouth) once daily
Treatment: Drugs: Canagliflozin (JNJ-28431754) 300 mg
One 300 mg capsule taken orally (by mouth) once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 8 years
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Secondary outcome [1]
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Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [2]
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Percentage of Participants With Progression of Albuminuria at the End-of-Treatment
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Assessment method [2]
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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.
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Timepoint [2]
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End of treatment (approximately 338 weeks)
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Secondary outcome [3]
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Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [4]
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Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment
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Assessment method [4]
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Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine.
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Timepoint [4]
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Baseline and End of treatment (approximately 338 weeks)
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Secondary outcome [5]
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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment
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Assessment method [5]
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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).
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Timepoint [5]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [6]
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Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [7]
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Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment
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Assessment method [7]
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Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed.
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Timepoint [7]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [8]
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Percent Change From Baseline in Body Weight at End-of-Treatment
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Assessment method [8]
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Percent change from baseline in body weight was assessed at the end of treatment.
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Timepoint [8]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [9]
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment
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Assessment method [9]
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Change from baseline in systolic blood pressure and diastolic blood pressure was assessed.
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Timepoint [9]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [10]
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Change From Baseline in Triglycerides Levels at End-of-Treatment
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Assessment method [10]
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Change from baseline in triglycerides levels was assessed.
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Timepoint [10]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [11]
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Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment
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Assessment method [11]
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Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed.
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Timepoint [11]
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Baseline and end of treatment (approximately 338 weeks)
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Secondary outcome [12]
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Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment
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Assessment method [12]
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Change from baseline in LDL-C to HDL-C ratio was assessed.
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Timepoint [12]
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Baseline and end of treatment (approximately 338 weeks)
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Eligibility
Key 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
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/02/2017
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Sample size
Target
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Accrual to date
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Final
4330
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Auchenflower
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Recruitment hospital [2]
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- Box Hill
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- Caboolture
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- Caringbah
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Recruitment hospital [5]
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- Clayton
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Recruitment hospital [6]
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- Daw Park
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Recruitment hospital [7]
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- East Ringwood
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Recruitment hospital [8]
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- Elizabeth Vale
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Recruitment hospital [9]
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- Hornsby, Nsw 2077
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Recruitment hospital [10]
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- Kippa Ring
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- Launceston
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- Liverpool
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- Melbourne
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- Milton
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- Parkville
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- Reservoir
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- Sherwood
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- Southport
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- St Leonards
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- West Heidelberg
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- Wollongong
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Recruitment hospital [22]
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- Woolloongabba
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Recruitment postcode(s) [1]
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- Auchenflower
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Recruitment postcode(s) [2]
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- Box Hill
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Recruitment postcode(s) [3]
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- Caboolture
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Recruitment postcode(s) [4]
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- Caringbah
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Recruitment postcode(s) [5]
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- Clayton
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Recruitment postcode(s) [6]
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- Daw Park
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Recruitment postcode(s) [7]
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- East Ringwood
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Recruitment postcode(s) [8]
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- Elizabeth Vale
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Recruitment postcode(s) [9]
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- Hornsby, Nsw 2077
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Recruitment postcode(s) [10]
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- Kippa Ring
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Recruitment postcode(s) [11]
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- Launceston
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Recruitment postcode(s) [12]
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- Liverpool
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Recruitment postcode(s) [13]
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- Melbourne
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Recruitment postcode(s) [14]
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- Milton
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Recruitment postcode(s) [15]
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- Parkville
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Recruitment postcode(s) [16]
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- Reservoir
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Recruitment postcode(s) [17]
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- Sherwood
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Recruitment postcode(s) [18]
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- Southport
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Recruitment postcode(s) [19]
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- St Leonards
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Recruitment postcode(s) [20]
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- West Heidelberg
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Recruitment postcode(s) [21]
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- Wollongong
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Recruitment postcode(s) [22]
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- Woolloongabba
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Recruitment outside Australia
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Alabama
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Arizona
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Florida
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Georgia
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Idaho
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Illinois
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Kansas
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Kentucky
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Maine
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Maryland
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Michigan
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Missouri
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Nebraska
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Argentina
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Buenos Aires
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Ciudad Autonma Buenos Aires
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Argentina
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Ciudad Autonoma De Buenos Aires
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Argentina
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Cordoba
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Argentina
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Argentina
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Godoy Cruz
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Argentina
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Mar Del Plata
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Argentina
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Rosario
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Argentina
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Santa Fe
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Belgium
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Arlon
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Bonheiden
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Brussel
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Edegem
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Genk
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British Columbia
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Manitoba
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Newfoundland and Labrador
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Ontario
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Kralupy Nad Vltavou
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Czechia
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Moravsky Krumlov
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Czechia
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Olomouc 9
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Czechia
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Ostrava
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Czechia
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Pisek
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Prague 5
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Praha 11
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Czechia
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Praha 8
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Czechia
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Praha
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Czechia
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Znojmo N/A
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Estonia
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Pärnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Amiens
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France
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Nimes Cedex 9
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France
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Pessac
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Berlin
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Germany
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Dortmund
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Germany
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Germany
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Hamburg
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Germany
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Künzing
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Germany
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Mainz
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Germany
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Münster
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Germany
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Pirna
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Germany
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Saarlouis
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Germany
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Speyer
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Germany
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Villingen-Schwenningen
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Hungary
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Budapest
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Hungary
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Kecskemet
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Hungary
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Mosonmagyaróvár
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Hungary
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Ahemadabad
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Ahmedabad
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Ambawadi
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India
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Bangalore, Karnataka
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India
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Bangalore
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Belgaum
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Calicut
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Cochin
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Coimbatore
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Ernakulam
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Hyderabad
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Indore
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India
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Karnal
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India
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Kerala
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Kochi
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India
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Kolkata
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India
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Lucknow
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India
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Mangalore
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India
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Mumbai
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India
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Mysore
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Nagpur
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India
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New Delhi
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India
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Patna
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India
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Pune
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India
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Rajkot
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India
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Trivandrum, Kerala
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India
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Vadodhara
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India
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Vijayawada
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India
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Visakhapatnam
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Israel
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Lierskogen
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Norway
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Moss
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Norway
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Oslo
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Lublin
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Poznan
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Torun
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Russian Federation
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kemerovo
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Penza
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Russian Federation
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Russian Federation
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Russia
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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St Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tula
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Russian Federation
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Tyumen
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Russian Federation
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Yaroslavl Nap
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Russian Federation
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Yaroslavl
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Spain
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Alicante
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Spain
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Almeria
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Spain
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Barcelona
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Spain
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Figueres
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Oviedo
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Spain
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Reus
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Spain
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Sabadell
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Spain
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San Juan De Alicante
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Spain
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Santiago De Compostela
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Spain
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Sevilla N/A
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Spain
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Valencia
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Spain
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Viladecans
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Sweden
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Borås
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Sweden
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Göteborg
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Sweden
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Helsingborg
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Sweden
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Lund
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Sweden
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Malmö
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Sweden
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Sweden
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Piteå
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Sweden
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Stockholm
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Sweden
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Uddevalla
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Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Odessa
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Ukraine
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Ternopol
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Ukraine
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Uzhgorod
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Ukraine
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Vinnitsa
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Ukraine
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Zaporozhye
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United Kingdom
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Belfast
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United Kingdom
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Blackburn
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United Kingdom
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Bolton
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United Kingdom
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Chorley
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United Kingdom
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Derby
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United Kingdom
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Glasgow
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United Kingdom
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Hull
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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Londonderry
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Randalstown
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United Kingdom
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Salford
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United Kingdom
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
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0
The George Institute for Global Health, Australia
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Address [1]
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0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01032629
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Trial related presentations / publications
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. 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. 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. 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. 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. 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 Aug;8(4):3447. doi: 10.1002/ehf2.13408. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
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