NCT01989754

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

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
5,813

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
25 countries

342 active sites

Status
completed

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 11, 2018

Completed
Last Updated

December 11, 2018

Status Verified

November 1, 2018

Enrollment Period

3.1 years

First QC Date

October 17, 2013

Results QC Date

November 19, 2018

Last Update Submit

November 19, 2018

Conditions

Keywords

AlbuminuriaCanagliflozinCardiovascular outcomesType 2 Diabetes MellitusT2DMJNJ-28431754Antihyperglycemic Agent

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)

EXPERIMENTAL

Each 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.

Drug: Canagliflozin, 100 mgDrug: Canagliflozin, 300 mg

Placebo

PLACEBO COMPARATOR

Each patient will receive placebo (inactive medication) once daily.

Drug: Placebo

Interventions

One placebo capsule taken orally (by mouth) once daily for 156 weeks

Placebo

One 100 mg capsule taken orally (by mouth) once daily

Canagliflozin (JNJ-28431754)

One 300 mg capsule taken orally (by mouth) once daily

Canagliflozin (JNJ-28431754)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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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Bois-Guillaume, 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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Le Creusot, France

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Narbonne, 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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Dresden, 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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Culiacán, Mexico

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Guadalajara, Mexico

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México, Mexico

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Pachuca, Mexico

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Querétaro, 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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Hoogeveen, 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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Poortvliet, Netherlands

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Rotterdam, Netherlands

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Utrecht, 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

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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.

  • Doi 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.

  • Nguyen 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.

  • Vaduganathan 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.

  • Natale 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.

  • Sharma 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.

  • Yu 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.

  • Fletcher 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.

  • Borisov 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.

  • Ferrannini 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.

  • Nunes 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.

  • 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.

  • 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.

  • Li 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Albuminuria

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Results Point of Contact

Title
Director Clinical Development
Organization
Janssen Research & Development, LLC

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

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

Locations