ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    CANVAS-R
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01989754
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
The George Institute for Global Health, Australia
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Albuminuria Drug: Placebo Drug: Canagliflozin, 100 mg Drug: Canagliflozin, 300 mg Phase 4

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  (Clinical Trial)
Actual Enrollment : 5813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 16, 2014
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989754


  Hide Study Locations
Locations
United States, Arkansas
Little Rock, Arkansas, United States
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
United States, Colorado
Denver, Colorado, United States
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
United States, Idaho
Meridian, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Valparaiso, Indiana, United States
United States, Kansas
Topeka, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
Mandeville, Louisiana, United States
Metairie, Louisiana, United States
United States, Maryland
Elkridge, Maryland, United States
United States, Michigan
Flint, Michigan, United States
United States, Mississippi
Picayune, Mississippi, United States
United States, Missouri
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Washington, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, North Carolina
Cornelius, North Carolina, United States
Hickory, North Carolina, United States
Mooresville, North Carolina, United States
United States, Ohio
Canal Fulton, Ohio, United States
Franklin, Ohio, United States
Mason, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Beaver, Pennsylvania, United States
Levittown, Pennsylvania, United States
Norristown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Tipton, Pennsylvania, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Tennessee
Jefferson City, Tennessee, United States
United States, Texas
Austin, Texas, United States
Pearland, Texas, United States
United States, Utah
Bountiful, Utah, United States
Draper, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
United States, Vermont
South Burlington, Vermont, United States
United States, Virginia
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Virginia Beach, Virginia, United States
United States, Washington
Spokane, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Wauwatosa, Wisconsin, United States
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
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Guelph, Ontario, Canada
Mississauga, Ontario, Canada
Oshawa, Ontario, Canada
Sarnia, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Laval, Quebec, Canada
Lévis, Quebec, Canada
Quebec City, Quebec, Canada
Saint Marc Des Carriéres, Quebec, Canada
Sherbrooke, Quebec, Canada
Westmont, Quebec, Canada
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 10, Czechia
Praha 1, 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 N/A, Italy
Roma, 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 N/A, Spain
Sevilla, 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
Sponsors and Collaborators
Janssen Research & Development, LLC
The George Institute for Global Health, Australia
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] September 1, 2016
Statistical Analysis Plan  [PDF] March 20, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01989754     History of Changes
Other Study ID Numbers: CR102647
2013-003050-25 ( EudraCT Number )
28431754DIA4003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 21, 2013    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Albuminuria
Canagliflozin
Cardiovascular outcomes
Type 2 Diabetes Mellitus
T2DM
JNJ-28431754
Antihyperglycemic Agent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Albuminuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs