A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R)

November 19, 2018 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in adult participants with Type 2 Diabetes Mellitus (T2DM), receiving standard of care for hyperglycemia and cardiovascular (CV) risk factors, who have either a history of a prior CV event or 2 or more risk factors for a CV event. Participants will be randomly assigned in a 1:1 ratio to canagliflozin or matching placebo to be taken once daily. Canagliflozin will be provided at a dose of 100 mg/day through Week 13 and then increased at the discretion of the investigator to a dose of 300 mg/day, if the participant requires additional glycemic control and is tolerating the 100 mg dose.

The study consists of a 2-week screening period and a double-blind treatment period lasting between 78 and 156 weeks; study completion is targeted for when the last subject randomized has approximately 78 weeks of follow-up or when 688 major adverse cardiovascular events are accumulated between CANVAS and CANVAS-R. A total of 5,700 participants are targeted to be recruited into the study. Participants can be either drug naïve to antihyperglycemic agents, using monotherapy, or using combination of antihyperglycemic therapy for the control of blood glucose levels.

The completion target was reached in February 2017.

Study Type

Interventional

Enrollment (Actual)

5813

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma De Buenos Aires, Argentina
      • Ciudad De Buenos Aires, Argentina
      • Cordoba, Argentina
      • Mar Del Plata, Argentina
      • Moron, Argentina
      • Rosario, Argentina
      • Zarate, Buenos Aires, Argentina
  • Australia
      • Box Hill, Australia
      • Cairns, Australia
      • Daw Park, Australia
      • Freemantle, Australia
      • Liverpool, Australia
      • Melbourne, Australia
      • Newcastle, Australia
      • Sherwood, Australia
      • Sydney, Australia
      • Tasmania, Australia
      • Woden, Australia
      • Woolloongabba, Australia
  • Belgium
      • Bonheiden, Belgium
      • Brugge, Belgium
      • Edegem, Belgium
      • Gent, Belgium
      • La Louvière, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Liÿge, Belgium
      • Merksem, Belgium
      • Ransart, Belgium
      • Roeselare, Belgium
      • Tessenderlo, Belgium
  • Brazil
      • Belem, Brazil
      • Belo Horizonte, Brazil
      • Campinas, Brazil
      • Caxias Do Sul, Brazil
      • Curitiba, Brazil
      • Fortaleza, Brazil
      • Mogi Das Cruzes, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Rio De Janeiro, Brazil
      • Sao Paulo, Brazil
      • São José Do Rio Preto, Brazil
      • São Paulo, Brazil
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Guelph, Ontario, Canada
      • Mississauga, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Sarnia, Ontario, Canada
      • Thornhill, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Laval, Quebec, Canada
      • Lévis, Quebec, Canada
      • Quebec City, Quebec, Canada
      • Saint Marc Des Carriéres, Quebec, Canada
      • Sherbrooke, Quebec, Canada
      • Westmont, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • China
      • Baotou, China
      • Beijing, China
      • Hangzhou, China
      • Jinan, China
      • Shenyang, China
      • Wuxi, China
  • Czechia
      • Beroun, Czechia
      • Ostrava, Czechia
      • Plzen, Czechia
      • Praha 1, Czechia
      • Praha 10, Czechia
      • Praha 4, Czechia
      • Praha 8, Czechia
      • Znojmo, Czechia
  • France
      • Amiens, France
      • Bois Guillaume, France
      • Bordeaux, France
      • Dijon, France
      • Grenoble, France
      • La Rochelle Cedex 1, France
      • Le Creusot, France
      • Narbonne Cedex, France
      • Paris, France
      • Poitiers, France
  • Germany
      • Aschaffenburg, Germany
      • Aßlar, Germany
      • Bad Oeynhausen, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Freiburg, Germany
      • Hannover, Germany
      • Kassel, Germany
      • Mainz, Germany
      • Neuwied, Germany
      • Saarbrücken, Germany
      • Villingen-Schwenningen, Germany
  • Hungary
      • Balatonfured, Hungary
      • Budapest, Hungary
      • Dunaújváros, Hungary
      • Eger, Hungary
      • Kecskemét, Hungary
      • Nagykanizsa, Hungary
      • Pecs, Hungary
      • Szekesfehervar, Hungary
      • Szikszó, Hungary
      • Szombathely, Hungary
      • Zalaegerszeg, Hungary
  • Italy
      • *Osenza*, Italy
      • Arenzano, Italy
      • Bologna, Italy
      • Catanzaro, Italy
      • Chieri (Torino), Italy
      • Firenze, Italy
      • Messina, Italy
      • Milano, Italy
      • Napoli, Italy
      • Ravenna, Italy
      • Roma, Italy
      • Roma N/A, Italy
      • Sesto San Giovanni (Milano), Italy
      • Verona, Italy
  • Korea, Republic of
      • Ansan, Korea, Republic of
      • Bucheon, Korea, Republic of
      • Busan, Korea, Republic of
      • Changwon, Korea, Republic of
      • Cheongju, Korea, Republic of
      • Daegu, Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
      • Iksan, Korea, Republic of
      • Incheon, Korea, Republic of
      • Jeonju, Korea, Republic of
      • Seongnam-Si, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
      • Ulsan, Korea, Republic of
      • Wonju-Si, Korea, Republic of
  • Malaysia
      • Batu Caves, Malaysia
      • Georgetown, Malaysia
      • Ipoh, Malaysia
      • Kelantan, Malaysia
      • Kota Bharu, Malaysia
      • Kuala Lumpur, Malaysia
      • Kuching, Malaysia
  • Mexico
      • Aguascalientes, Mexico
      • Celaya, Mexico
      • Cuernavaca, Mexico
      • Culiacan, Mexico
      • Guadalajara, Mexico
      • Mexico, Mexico
      • Pachuca De Soto, Mexico
      • Queretaro, Mexico
      • San Luis Potosi, Mexico
      • Tampico, Mexico
  • Netherlands
      • Almelo, Netherlands
      • Almere, Netherlands
      • Amersfoort, Netherlands
      • Amsterdam, Netherlands
      • Dordrecht, Netherlands
      • Eindhoven, Netherlands
      • Groningen, Netherlands
      • Hardenberg, Netherlands
      • Hoogeveen, Netherlands
      • Hoogezand, Netherlands
      • Kloosterhaar, Netherlands
      • Leiden, Netherlands
      • Meppel, Netherlands
      • Poortvliet, Netherlands
      • Rotterdam, Netherlands
      • Utrecht, Netherlands
      • Velp, Netherlands
      • Waalwijk, Netherlands
      • Wamel, Netherlands
      • Zoetermeer, Netherlands
      • Zwijndrecht, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Newtown, New Zealand
      • Palmerston North, New Zealand
      • Rotorua, New Zealand
      • Tauranga, New Zealand
      • Wellington, New Zealand
  • Poland
      • Bialystok, Poland
      • Bydgoszcz, Poland
      • Chrzanow, Poland
      • Gdansk, Poland
      • Grodzisk Mazowiecki, Poland
      • Katowice, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Oswiecim, Poland
      • Torun, Poland
      • Tychy, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • Puerto Rico
      • Ponce Pr, Puerto Rico
      • Trujillo Alto, Puerto Rico
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Barnaul, Russian Federation
      • Chelyabinsk, Russian Federation
      • Kemerovo, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Penza, Russian Federation
      • Rostov-On-Don, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Samara, Russian Federation
      • Saratov, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • St-Petersburg, Russian Federation
      • Syktyvkar, Russian Federation
      • Tyumen, Russian Federation
      • Vsevolzhsk, Russian Federation
      • Yaroslavl, Russian Federation
  • Spain
      • A Coruna, Spain
      • Alcalá De Henares, Spain
      • Alicante, Spain
      • Almeria, Spain
      • Alzira, Spain
      • Barcelona, Spain
      • Ciudad Real, Spain
      • Cordoba, Spain
      • Ferrol, Spain
      • Figueres, Spain
      • Galdakao, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Móstoles, Spain
      • Palma De Mallorca, Spain
      • Sabadell, Spain
      • San Sebastian De Los Reyes, Spain
      • Sant Joan D'Alacant, Spain
      • Santa Cruz De Tenerife, Spain
      • Santiago De Compostela, Spain
      • Segovia, Spain
      • Sevilla, Spain
      • Sevilla N/A, Spain
      • Valencia, Spain
      • Viladecans, Spain
  • Sweden
      • Borås, Sweden
      • Goteborg, Sweden
      • Helsingborg, Sweden
      • Karlstad, Sweden
      • Linköping, Sweden
      • Lund, Sweden
      • Malmo, Sweden
      • Stockholm, Sweden
      • Uddevalla, Sweden
      • Uppsala, Sweden
      • Vallingby, Sweden
      • Västra Frölunda, Sweden
  • Taiwan
      • Kaohsiung County, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Tiachung, Taiwan
      • Xindian, Taiwan
  • Ukraine
      • Cherkasy, Ukraine
      • Chernivtsy, Ukraine
      • Dnipropetrovsk, Ukraine
      • Ivan-Frankivsk, Ukraine
      • Ivano-Frankovsk, Ukraine
      • Kharkiv, Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Odesa, Ukraine
      • Odessa, Ukraine
      • Poltava, Ukraine
      • Sumy, Ukraine
      • Ternopil, Ukraine
      • Uzhgorod, Ukraine
      • Vinnitsa, Ukraine
      • Vinnytsya, Ukraine
      • Zaporizhzhia, Ukraine
      • Zaporizhzhya, Ukraine
  • United Kingdom
      • Addlestone, United Kingdom
      • Belfast, United Kingdom
      • Birmingham, United Kingdom
      • Blackburn, United Kingdom
      • Bristol, United Kingdom
      • Bury St Edmunds, United Kingdom
      • Chesterfield, United Kingdom
      • Derby, United Kingdom
      • Doncaster, United Kingdom
      • Ipswich, United Kingdom
      • Leicester, United Kingdom
      • Liverpool, United Kingdom
      • Manchester, United Kingdom
      • Salford, United Kingdom
      • Taunton, United Kingdom
      • Torquay, United Kingdom
      • Truro, United Kingdom
      • Wellingborough, United Kingdom
      • Welwyn Garden City, United Kingdom
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Carmichael, California, United States
      • Concord, California, United States
      • Pismo Beach, California, United States
      • Roseville, California, United States
      • Thousand Oaks, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • Opa-locka, Florida, United States
      • Orlando, Florida, United States
      • Palm Harbor, Florida, United States
      • Tampa, Florida, United States
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Valparaiso, Indiana, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Mandeville, Louisiana, United States
      • Metairie, Louisiana, United States
    • Maryland
      • Elkridge, Maryland, United States
    • Michigan
      • Flint, Michigan, United States
    • Mississippi
      • Picayune, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
      • Washington, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • North Carolina
      • Cornelius, North Carolina, United States
      • Hickory, North Carolina, United States
      • Mooresville, North Carolina, United States
    • Ohio
      • Canal Fulton, Ohio, United States
      • Franklin, Ohio, United States
      • Mason, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Levittown, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Tipton, Pennsylvania, United States
    • South Carolina
      • Greer, South Carolina, United States
    • Tennessee
      • Jefferson City, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Pearland, Texas, United States
    • Utah
      • Bountiful, Utah, United States
      • Draper, Utah, United States
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Vermont
      • South Burlington, Vermont, United States
    • Virginia
      • Falls Church, Virginia, United States
      • Norfolk, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Wauwatosa, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Canagliflozin (JNJ-28431754)
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 mg
One 100 mg capsule taken orally (by mouth) once daily
Drug: Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily
PLACEBO_COMPARATOR: Placebo
Each patient will receive placebo (inactive medication) once daily.
Drug: Placebo
One placebo capsule taken orally (by mouth) once daily for 156 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of Albuminuria
Time Frame: Up to 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
Time Frame: Approximately 3 years
Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
Approximately 3 years
Cardiovascular (CV) Death
Time Frame: Approximately 3 years
Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

The George Institute for Global Health, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 16, 2014

Primary Completion (ACTUAL)

February 23, 2017

Study Completion (ACTUAL)

February 23, 2017

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (ESTIMATE)

November 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR102647
  • 2013-003050-25 (EUDRACT_NUMBER)
  • 28431754DIA4003 (OTHER: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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