A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
CANVAS-R
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus
3 other identifiers
interventional
5,813
25 countries
342
Brief Summary
The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Jan 2014
Longer than P75 for phase_4 diabetes-mellitus-type-2
342 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedStudy Start
First participant enrolled
January 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2017
CompletedResults Posted
Study results publicly available
December 11, 2018
CompletedDecember 11, 2018
November 1, 2018
3.1 years
October 17, 2013
November 19, 2018
November 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of Albuminuria
Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio \[UACR\] 30 to 300 milligram per gram \[mg/g\]) or macroalbuminuria (Albumin/creatinine ratio \[ACR\] of greater than \[\>\] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than \[\<\] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (\>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR\>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event.
Up to 3 years
Secondary Outcomes (2)
Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
Approximately 3 years
Cardiovascular (CV) Death
Approximately 3 years
Study Arms (2)
Canagliflozin (JNJ-28431754)
EXPERIMENTALEach patient will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 13 weeks, then the dose may be increased to 300 mg once daily.
Placebo
PLACEBO COMPARATOREach patient will receive placebo (inactive medication) once daily.
Interventions
One 100 mg capsule taken orally (by mouth) once daily
One 300 mg capsule taken orally (by mouth) once daily
Eligibility Criteria
You may qualify if:
- Must have a diagnosis of type 2 diabetes mellitus
- Must have inadequate diabetes control (as defined by glycosylated hemoglobin level \>=7.0% to \<=10.5% at screening)
- Greater than or equal to (\>=) 30 yrs old with history of cardiovascular (CV) event, or \>= 50 yrs old with high risk of CV events
- Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels.
You may not qualify if:
- 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 episode within 6 months before screening
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Ongoing, inadequately controlled thyroid disorder
- Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (342)
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Little Rock, Arkansas, United States
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Carmichael, California, United States
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Concord, California, United States
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Pismo Beach, California, United States
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Roseville, California, United States
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Thousand Oaks, California, United States
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Denver, Colorado, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Opa-locka, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Tampa, Florida, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Valparaiso, Indiana, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Mandeville, Louisiana, United States
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Metairie, Louisiana, United States
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Elkridge, Maryland, United States
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Flint, Michigan, United States
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Picayune, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Washington, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Cornelius, North Carolina, United States
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Hickory, North Carolina, United States
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Mooresville, North Carolina, United States
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Canal Fulton, Ohio, United States
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Franklin, Ohio, United States
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Mason, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Beaver, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Greer, South Carolina, United States
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Jefferson City, Tennessee, United States
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Austin, Texas, United States
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Pearland, Texas, United States
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Bountiful, Utah, United States
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Draper, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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South Burlington, Vermont, United States
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Falls Church, Virginia, United States
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Norfolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Wauwatosa, Wisconsin, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Morón, Argentina
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Rosario, Argentina
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Zarate, Buenos Aires, Argentina
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Box Hill, Australia
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Cairns, Australia
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Daw Park, Australia
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Freemantle, Australia
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Liverpool, Australia
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Melbourne, Australia
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Newcastle, Australia
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Sherwood, Australia
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Sydney, Australia
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Tasmania, Australia
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Woden, Australia
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Woolloongabba, Australia
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Bonheiden, Belgium
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Bruges, Belgium
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Edegem, Belgium
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Ghent, Belgium
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La Louvière, Belgium
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Leuven, Belgium
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Liège, Belgium
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Liÿge, Belgium
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Merksem, Belgium
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Ransart, Belgium
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Roeselare, Belgium
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Tessenderlo, Belgium
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Belém, Brazil
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Belo Horizonte, Brazil
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Campinas, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Fortaleza, Brazil
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Mogi das Cruzes, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Coquitlam, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Guelph, Ontario, Canada
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Mississauga, Ontario, Canada
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Oshawa, Ontario, Canada
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Sarnia, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Lévis, Quebec, Canada
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Québec, Quebec, Canada
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Saint Marc Des Carriéres, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Westmont, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Baotou, China
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Beijing, China
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Hangzhou, China
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Jinan, China
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Shenyang, China
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Wuxi, China
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Beroun, Czechia
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Ostrava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Znojmo, Czechia
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Amiens, France
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Bordeaux, France
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Dijon, France
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Grenoble, France
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La Rochelle, France
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Paris, France
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Poitiers, France
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Aschaffenburg, Germany
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Aßlar, Germany
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Bad Oeynhausen, Germany
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Dortmund, Germany
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Freiburg im Breisgau, Germany
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Hanover, Germany
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Kassel, Germany
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Mainz, Germany
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Neuwied, Germany
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Saarbrücken, Germany
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Villingen-Schwenningen, Germany
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Balatonfüred, Hungary
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Budapest, Hungary
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Dunaújváros, Hungary
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Eger, Hungary
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Kecskemét, Hungary
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Nagykanizsa, Hungary
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Pécs, Hungary
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Székesfehérvár, Hungary
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Szikszó, Hungary
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Szombathely, Hungary
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Zalaegerszeg, Hungary
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*Osenza*, Italy
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Arenzano, Italy
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Bologna, Italy
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Catanzaro, Italy
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Chieri (Torino), Italy
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Florence, Italy
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Messina, Italy
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Milan, Italy
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Napoli, Italy
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Ravenna, Italy
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Roma, Italy
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Sesto San Giovanni (Milano), Italy
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Verona, Italy
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Batu Caves, Malaysia
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George Town, Malaysia
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Ipoh, Malaysia
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Kelantan, Malaysia
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Kota Bharu, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Aguascalientes, Mexico
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Celaya, Mexico
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Cuernavaca, Mexico
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México, Mexico
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Pachuca, Mexico
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San Luis Potosí City, Mexico
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Tampico, Mexico
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Almelo, Netherlands
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Almere Stad, Netherlands
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Dordrecht, Netherlands
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Eindhoven, Netherlands
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Groningen, Netherlands
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Hardenberg, Netherlands
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Hoogezand, Netherlands
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Kloosterhaar, Netherlands
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Leiden, Netherlands
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Meppel, Netherlands
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Rotterdam, Netherlands
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Velp, Netherlands
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Waalwijk, Netherlands
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Wamel, Netherlands
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Zoetermeer, Netherlands
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Zwijndrecht, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Newtown, New Zealand
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Palmerston North, New Zealand
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Rotorua, New Zealand
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Tauranga, New Zealand
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Wellington, New Zealand
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Bialystok, Poland
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Bydgoszcz, Poland
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Chrzanów, Poland
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Gdansk, Poland
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Grodzisk Mazowiecki, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Oświęcim, Poland
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Torun, Poland
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Tychy, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Ponce Pr, Puerto Rico
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Trujillo Alto, Puerto Rico
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Arkhangelsk, Russia
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Barnaul, Russia
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Chelyabinsk, Russia
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Kemerovo, Russia
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Nizhny Novgorod, Russia
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Penza, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Smolensk, Russia
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Syktyvkar, Russia
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Tyumen, Russia
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Vsevolzhsk, Russia
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Yaroslavl, Russia
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Ansan, South Korea
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Bucheon-si, South Korea
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Busan, South Korea
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Changwon, South Korea
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Cheongju-si, South Korea
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Daegu, South Korea
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Gyeonggi-do, South Korea
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Iksan, South Korea
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Incheon, South Korea
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Jeonju, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Ulsan, South Korea
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Wŏnju, South Korea
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A Coruña, Spain
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Alcalá de Henares, Spain
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Alicante, Spain
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Almería, Spain
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Alzira, Spain
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Barcelona, Spain
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Ciudad Real, Spain
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Córdoba, Spain
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Ferrol, Spain
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Figueres, Spain
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Galdakao, Spain
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Madrid, Spain
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Málaga, Spain
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Móstoles, Spain
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Palma de Mallorca, Spain
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Sabadell, Spain
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San Sebastián de los Reyes, Spain
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Sant Joan d'Alacant, Spain
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Santa Cruz de Tenerife, Spain
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Santiago de Compostela, Spain
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Segovia, Spain
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Seville, Spain
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Valencia, Spain
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Viladecans, Spain
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Borås, Sweden
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Gothenburg, Sweden
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Helsingborg, Sweden
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Karlstad, Sweden
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Linköping, Sweden
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Lund, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Uddevalla, Sweden
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Uppsala, Sweden
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Vällingby, Sweden
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Västra Frölunda, Sweden
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Kaohsiung County, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Tiachung, Taiwan
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Xindian, Taiwan
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Cherkasy, Ukraine
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Chernivtsy, Ukraine
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Dnipropetrovsk, Ukraine
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Ivan-Frankivsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Vinnitsa, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
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Zaporizhzhya, Ukraine
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Addlestone, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Blackburn, United Kingdom
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Bristol, United Kingdom
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Bury St Edmunds, United Kingdom
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Chesterfield, United Kingdom
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Derby, United Kingdom
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Doncaster, United Kingdom
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Ipswich, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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Manchester, United Kingdom
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Salford, United Kingdom
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Taunton, United Kingdom
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Torquay, United Kingdom
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Truro, United Kingdom
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Wellingborough, United Kingdom
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Welwyn Garden City, United Kingdom
Related Publications (27)
Januzzi JLJ, Sattar N, Vaduganathan M, Magaret CA, Rhyne RF, Liu Y, Masson S, Butler J, Hansen MK. A validated multivariable machine learning model to predict cardio-kidney risk in diabetic kidney disease. Cardiovasc Diabetol. 2025 May 15;24(1):213. doi: 10.1186/s12933-025-02779-5.
PMID: 40375260DERIVEDDoi Y, Hamano T, Yamaguchi O, Isaka Y. Canagliflozin may increase thromboembolic events in males with erythrocytosis but not in females. Blood Adv. 2025 Jul 8;9(13):3202-3212. doi: 10.1182/bloodadvances.2025016320.
PMID: 40239057DERIVEDNguyen TN, Yu J, Perkovic V, Jardine M, Mahaffey KW, Chow CK, Arnott C, Lindley RI. The Efficacy and Safety of Canagliflozin by Frailty Status in Participants of the CANVAS and CREDENCE Trials. J Am Geriatr Soc. 2025 Jun;73(6):1787-1796. doi: 10.1111/jgs.19444. Epub 2025 Mar 19.
PMID: 40105285DERIVEDVaduganathan M, Cannon CP, Jardine MJ, Heerspink HJL, Arnott C, Neuen BL, Sarraju A, Gogate J, Seufert J, Neal B, Perkovic V, Mahaffey KW, Kosiborod MN. Effects of canagliflozin on total heart failure events across the kidney function spectrum: Participant-level pooled analysis from the CANVAS Program and CREDENCE trial. Eur J Heart Fail. 2024 Sep;26(9):1967-1975. doi: 10.1002/ejhf.3292. Epub 2024 Jun 26.
PMID: 38932575DERIVEDNatale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVEDSharma A, Razaghizad A, Joury A, Levin A, Bajaj HS, Mancini GBJ, Wong NC, Slee A, Ang FG, Rapattoni W, Neuen BL, Arnott C, Perkovic V, Mahaffey KW. Primary and Secondary Cardiovascular and Kidney Prevention With Canagliflozin: Insights From the CANVAS Program and CREDENCE Trial. J Am Heart Assoc. 2024 Feb 6;13(3):e031586. doi: 10.1161/JAHA.123.031586. Epub 2024 Jan 19.
PMID: 38240199DERIVEDYu J, Sweeting AN, Gianacas C, Houston L, Lee V, Fletcher RA, Perkovic V, Li Q, Neuen BL, Berwanger O, Heerspink HJL, de Zeeuw D, Arnott C. The effects of canagliflozin in type 2 diabetes in subgroups defined by population-specific body mass index: Insights from the CANVAS Program and CREDENCE trial. Diabetes Obes Metab. 2023 Dec;25(12):3724-3735. doi: 10.1111/dom.15267. Epub 2023 Sep 6.
PMID: 37671609DERIVEDFletcher RA, Arnott C, Rockenschaub P, Schutte AE, Carpenter L, Vaduganathan M, Agarwal R, Bakris G, Chang TI, Heerspink HJL, Jardine MJ, Mahaffey KW, Neal B, Pollock C, Jun M, Rodgers A, Perkovic V, Neuen BL. Canagliflozin, Blood Pressure Variability, and Risk of Cardiovascular, Kidney, and Mortality Outcomes: Pooled Individual Participant Data From the CANVAS and CREDENCE Trials. J Am Heart Assoc. 2023 Jul 4;12(13):e028516. doi: 10.1161/JAHA.122.028516. Epub 2023 Jun 22.
PMID: 37345834DERIVEDBorisov AN, Kutz A, Christ ER, Heim MH, Ebrahimi F. Canagliflozin and Metabolic Associated Fatty Liver Disease in Patients With Diabetes Mellitus: New Insights From CANVAS. J Clin Endocrinol Metab. 2023 Oct 18;108(11):2940-2949. doi: 10.1210/clinem/dgad249.
PMID: 37149821DERIVEDFerrannini G, Pollock C, Natali A, Yavin Y, Mahaffey KW, Ferrannini E. Extremes of both weight gain and weight loss are associated with increased incidence of heart failure and cardiovascular death: evidence from the CANVAS Program and CREDENCE. Cardiovasc Diabetol. 2023 Apr 29;22(1):100. doi: 10.1186/s12933-023-01832-5.
PMID: 37120538DERIVEDNunes JC, Yu J, Arnott C, Jardine MJ, Perkovic V, Mahaffey KW. Canagliflozin, mental health adverse events and diabetes: Exploratory analysis of the CREDENCE trial and CANVAS Program. Diabetes Obes Metab. 2022 Dec;24(12):2459-2464. doi: 10.1111/dom.14832. Epub 2022 Aug 19. No abstract available.
PMID: 35938182DERIVEDYoung 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.
PMID: 34448033DERIVEDYu 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.
PMID: 33826709DERIVEDYu 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.
PMID: 33595905DERIVEDNeuen 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.
PMID: 32971190DERIVEDOshima 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.
PMID: 32694216DERIVEDMatthews 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.
PMID: 32691499DERIVEDLi J, Woodward M, Perkovic V, Figtree GA, Heerspink HJL, Mahaffey KW, de Zeeuw D, Vercruysse F, Shaw W, Matthews DR, Neal B. Mediators of the Effects of Canagliflozin on Heart Failure in Patients With Type 2 Diabetes. JACC Heart Fail. 2020 Jan;8(1):57-66. doi: 10.1016/j.jchf.2019.08.004. Epub 2019 Oct 29.
PMID: 31676303DERIVEDZhou 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.
PMID: 31399845DERIVEDFigtree 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.
PMID: 30882240DERIVEDZhou 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.
PMID: 30591006DERIVEDNeuen 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.
PMID: 29941478DERIVEDPerkovic 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.
PMID: 29937267DERIVEDWittbrodt 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.
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PMID: 28605608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Development
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2013
First Posted
November 21, 2013
Study Start
January 16, 2014
Primary Completion
February 23, 2017
Study Completion
February 23, 2017
Last Updated
December 11, 2018
Results First Posted
December 11, 2018
Record last verified: 2018-11