AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3CANVASNCT01032629

CANVAS - CANagliflozin cardioVascular Assessment Study

A Phase 3 study testing Canagliflozin (JNJ-28431754) 100 mg and Canagliflozin (JNJ-28431754) 300 mg in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Janssen Research & Development, LLC at 305 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. Read more about this study

Who is it for?
Ages 30 years and older
What is being tested?
Canagliflozin (JNJ-28431754) 100 mg and Canagliflozin (JNJ-28431754) 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,330 participants
Where
305 sitesin 25 countries
Study dates
9 Dec 2009to 22 Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events
  • Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be either (1) not currently on diabetes drug therapy or (2) on therapy with any approved class of diabetes drugs

Who cannot join

  • A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening

Trial locations and contacts

305 sites in 25 countries.

305 sites in 25 countries

United States58 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Auburn, Maine

  • Study site

    Beaver, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Camden, New Jersey

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Dallas, Texas

  • Study site

    Danville, Virginia

  • Study site

    Doral, Florida

  • Study site

    Draper, Utah

  • Study site

    Duluth, Georgia

  • Study site

    Eagle, Idaho

  • Study site

    Flushing, New York

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Gallipolis, Ohio

  • Study site

    Greenville, South Carolina

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    La Mesa, California

  • Study site

    Lexington, Kentucky

  • Study site

    Los Gatos, California

  • Study site

    Mentor, Ohio

  • Study site

    Meridian, Idaho

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Norristown, Pennsylvania

  • Study site

    Odessa, Texas

  • Study site

    Omaha, Nebraska

  • Study site

    Oxon Hill, Maryland

  • Study site

    Peoria, Illinois

  • Study site

    Pismo Beach, California

  • Study site

    Plantation, Florida

  • Study site

    Richmond, Virginia

  • Study site

    Royal Oak, Michigan

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Sandy City, Utah

  • Study site

    Sayre, Pennsylvania

  • Study site

    Scarborough, Maine

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Stockton, California

  • Study site

    Tacoma, Washington

  • Study site

    Temple, Texas

  • Study site

    The Bronx, New York

  • Study site

    Toledo, Ohio

  • Study site

    Topeka, Kansas

  • Study site

    Tucson, Arizona

  • Study site

    Walnut Creek, California

  • Study site

    West Jordan, Utah

Other trials in United States

India31 sites

  • Study site

    Ahemadabad

  • Study site

    Ahmedabad

  • Study site

    Ambawadi

  • Study site

    Bangalore

  • Study site

    Bangalore, Karnataka

  • Study site

    Belagavi

  • Study site

    Calicut

  • Study site

    Chennai

  • Study site

    Coimbatore

  • Study site

    Ernākulam

  • Study site

    Ghaziabad

  • Study site

    Hyderabad

  • Study site

    Indore

  • Study site

    Jaipur

  • Study site

    Karnāl

  • Study site

    Kerala

  • Study site

    Kochi

  • Study site

    Kolkata

  • Study site

    Lucknow

  • Study site

    Mangalore

  • Study site

    Mumbai

  • Study site

    Mysore

  • Study site

    Nagpur

  • Study site

    New Delhi

  • Study site

    Patna

  • Study site

    Pune

  • Study site

    Rajkot

  • Study site

    Trivandrum, Kerala

  • Study site

    Vadodhara

  • Study site

    Vijayawada

  • Study site

    Visakhapatnam

Other trials in India

Australia22 sites

  • Study site

    Auchenflower

  • Study site

    Box Hill

  • Study site

    Caboolture

  • Study site

    Caringbah

  • Study site

    Clayton

  • Study site

    Daw Park

  • Study site

    East Ringwood

  • Study site

    Elizabeth Vale

  • Study site

    Hornsby, Nsw 2077

  • Study site

    Kippa-Ring

  • Study site

    Launceston

  • Study site

    Liverpool

  • Study site

    Melbourne

  • Study site

    Milton

  • Study site

    Parkville

  • Study site

    Reservoir

  • Study site

    Sherwood

  • Study site

    Southport

  • Study site

    St Leonards

  • Study site

    West Heidelberg

  • Study site

    Wollongong

  • Study site

    Woolloongabba

Other trials in Australia

Russia22 sites

  • Study site

    Arkhangelsk

  • Study site

    Chelyabinsk

  • Study site

    Kemerovo

  • Study site

    Kirov

  • Study site

    Kursk

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Penza

  • Study site

    Rostov-on-Don

  • Study site

    Russia

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Smolensk

  • Study site

    Tomsk

  • Study site

    Tula

  • Study site

    Tyumen

  • Study site

    Yaroslavl

  • Study site

    Yaroslavl Nap

  • Study site

    Yekaterinburg

Other trials in Russia

Canada16 sites

  • Study site

    Brampton, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Coquitlam, British Columbia

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Laval, Quebec

  • Study site

    Lévis, Quebec

  • Study site

    London, Ontario

  • Study site

    Mississauga, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Nemarket, Ontario

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Val-Bélair, Quebec

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Netherlands16 sites

  • Study site

    Almelo

  • Study site

    Almere Stad

  • Study site

    Amsterdam

  • Study site

    Arnhem

  • Study site

    Delft

  • Study site

    Den Helder

  • Study site

    Dordrecht

  • Study site

    Eindhoven

  • Study site

    Groningen

  • Study site

    Hoorn

  • Study site

    Rotterdam

  • Study site

    Tilburg

  • Study site

    Utrecht

  • Study site

    Velp Gld

  • Study site

    Zoetermeer

  • Study site

    Zwijndrecht

Other trials in Netherlands

United Kingdom15 sites

  • Study site

    Belfast

  • Study site

    Blackburn

  • Study site

    Bolton

  • Study site

    Chorley

  • Study site

    Derby

  • Study site

    Glasgow

  • Study site

    Hull

  • Study site

    Leicester

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Londonderry

  • Study site

    Manchester

  • Study site

    Randalstown

  • Study site

    Salford

  • Study site

    York

Other trials in United Kingdom

Poland14 sites

  • Study site

    Bialystok

  • Study site

    Ciechocinek

  • Study site

    Gniewkowo

  • Study site

    Grudziądz

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Płock

  • Study site

    Poznan

  • Study site

    Rzeszów

  • Study site

    Sławków

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Spain14 sites

  • Study site

    Alicante

  • Study site

    Almería

  • Study site

    Barcelona

  • Study site

    Figueres

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Oviedo

  • Study site

    Reus

  • Study site

    Sabadell

  • Study site

    Sant Joan d'Alacant

  • Study site

    Santiago de Compostela

  • Study site

    Seville

  • Study site

    Valencia

  • Study site

    Viladecans

Other trials in Spain

Germany11 sites

  • Study site

    Berlin

  • Study site

    Dortmund

  • Study site

    Dresden

  • Study site

    Hamburg

  • Study site

    Künzing

  • Study site

    Mainz

  • Study site

    Münster

  • Study site

    Pirna

  • Study site

    Saarlouis

  • Study site

    Speyer

  • Study site

    Villingen-Schwenningen

Other trials in Germany

Ukraine10 sites

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Odesa

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Argentina9 sites

  • Study site

    Buenos Aires

  • Study site

    Capital Federal

  • Study site

    Ciudad Autonma Buenos Aires

  • Study site

    Córdoba

  • Study site

    Corrientes

  • Study site

    Godoy Cruz

  • Study site

    Mar del Plata

  • Study site

    Rosario

  • Study site

    Santa Fe

Other trials in Argentina

Norway9 sites

  • Study site

    Ålesund

  • Study site

    Asker

  • Study site

    Bekkestua

  • Study site

    Elverum

  • Study site

    Hamar

  • Study site

    Lierskogen

  • Study site

    Moss

  • Study site

    Oslo

  • Study site

    Skedsmokorset

Other trials in Norway

Sweden9 sites

  • Study site

    Borås

  • Study site

    Gothenburg

  • Study site

    Helsingborg

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Oskarshamn

  • Study site

    Piteå

  • Study site

    Stockholm

  • Study site

    Uddevalla

Other trials in Sweden

Czechia7 sites

  • Study site

    Kralupy nad Vltavou

  • Study site

    Moravský Krumlov

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Písek

  • Study site

    Prague

  • Study site

    Znojmo

Other trials in Czechia

Malaysia7 sites

  • Study site

    George Town

  • Study site

    Johor Bahru

  • Study site

    Kota Bharu

  • Study site

    Kuala Lumpur

  • Study site

    Petaling Jaya

  • Study site

    Pulau Pinang

  • Study site

    Subang Jaya

Other trials in Malaysia

Belgium6 sites

  • Study site

    Arlon

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Edegem

  • Study site

    Genk

  • Study site

    Leuven

Other trials in Belgium

Mexico6 sites

  • Study site

    Aguascalientes

  • Study site

    Celaya

  • Study site

    Durango

  • Study site

    Guadalajara

  • Study site

    Mexico City

  • Study site

    Monterrey

Other trials in Mexico

New Zealand5 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

Estonia4 sites

  • Study site

    Pärnu

  • Study site

    Tallinn

  • Study site

    Tartu

  • Study site

    Viljandi

Other trials in Estonia

Hungary4 sites

  • Study site

    Budapest

  • Study site

    Kecskemét

  • Study site

    Mosonmagyaróvár

  • Study site

    Zalaegerszeg

Other trials in Hungary

Israel4 sites

  • Study site

    Beersheba

  • Study site

    Holon

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

Other trials in Israel

France3 sites

  • Study site

    Amiens

  • Study site

    Nîmes

  • Study site

    Pessac

Other trials in France

Colombia2 sites

  • Study site

    Bogotá

  • Study site

    Floridablanca

Other trials in Colombia

Luxembourg1 site

  • Study site

    Luxembourg

Other trials in Luxembourg

About this study

Official title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

Read the detailed description

The study will evaluate canagliflozin compared to placebo on CV events including CV death, heart attack, and stroke in patients with T2DM, whose diabetes is not well controlled at the beginning of the study and who have a history of CV events or have a high risk for CV events. The study includes 3 substudies which will compare the effectiveness of lowering blood glucose and assess the safety of canagliflozin relative to placebo in patients receiving specific commonly-used diabetes agents. 4,330 participants will be randomly assigned to treatment with 1 of 2 doses of canagliflozin (100 or 300 mg) or placebo, in a 1:1:1 ratio. This study was originally designed to last for up to 9 years. As per FDA post-marketing requirements for canagliflozin, the study's last subject last visit will now occur when enough MACE events (ie, CV death, nonfatal myocardial infarction, nonfatal stroke) are accumulated between the CANVAS (this study) and CANVAS-R studies. The completion target was reached in February 2017.

Being tested
Placebo, Canagliflozin (JNJ-28431754) 100 mg, Canagliflozin (JNJ-28431754) 300 mg
Keywords
Diabetes, Type 2 diabetes mellitus, Cardiovascular risk, Cardiovascular outcomes, Canagliflozin (JNJ-28431754), Placebo
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    One placebo capsule taken orally (by mouth) once daily

  • Canagliflozin (JNJ-28431754) 100 mgDrug

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

  • Canagliflozin (JNJ-28431754) 300 mgDrug

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

Study groups in NCT01032629
Study groupRoleWhat they receive
PlaceboPlacebo comparatorEach patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study
Receives: Drug: Placebo
Canagliflozin (JNJ-28431754) 100 mgExperimentalEach patient will receive canagliflozin (JNJ-28431754) 100 mg once daily on background standard of care for diabetes once daily for the duration of the study
Receives: Drug: Canagliflozin (JNJ-28431754) 100 mg
Canagliflozin (JNJ-28431754) 300 mgExperimentalEach patient will receive canagliflozin (JNJ-28431754) 300 mg once daily on background standard of care for diabetes once daily for the duration of the study
Receives: Drug: Canagliflozin (JNJ-28431754) 300 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke

    MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.

    Measured: Up to approximately 8 years

Secondary outcomes (12)

  1. Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)

    The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  2. Percentage of Participants With Progression of Albuminuria at the End-of-Treatment

    Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to [>=] 30 milligram per gram (mg/g) and less than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed.

    Measured: End of treatment (approximately 338 weeks)

  3. Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment

    A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  4. Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment

    Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine.

    Measured: Baseline and End of treatment (approximately 338 weeks)

  5. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment

    Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m^2) = 175 * (serum creatinine) ^ 1.154 * (Age) ^-0.203 *(0.742 if female) * (1.21 if Black).

    Measured: Baseline and end of treatment (approximately 338 weeks)

  6. Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment

    Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  7. Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment

    Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  8. Percent Change From Baseline in Body Weight at End-of-Treatment

    Percent change from baseline in body weight was assessed at the end of treatment.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  9. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment

    Change from baseline in systolic blood pressure and diastolic blood pressure was assessed.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  10. Change From Baseline in Triglycerides Levels at End-of-Treatment

    Change from baseline in triglycerides levels was assessed.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  11. Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment

    Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed.

    Measured: Baseline and end of treatment (approximately 338 weeks)

  12. Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment

    Change from baseline in LDL-C to HDL-C ratio was assessed.

    Measured: Baseline and end of treatment (approximately 338 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2009 (estimated)
  2. Study start9 Dec 2009
  3. Primary completion22 Feb 2017
  4. Study completion22 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01032629
Sponsor's protocol ID
CR016627
Other IDs
28431754DIA3008, 2009-012140-16, 2009
Acronym
CANVAS
Status last verified
Nov 2018
First submitted
10 Dec 2009
Last updated
7 Dec 2018
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Moedt E, Koshino A, Jongs N, Ju W, Nair V, Kretzler M, Hansen MK, Arnott CG, Wheeler DC, Rossing P, Coca SG, Hammarstedt A, Greasley PJ, Bjornstad P, Bakker SJL, Heerspink HJL. Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition. J Am Soc Nephrol. 2026 Apr 2. doi: 10.1681/ASN.0000001086. Online ahead of print.

    PubMed 41926219

  • Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6.

    PubMed 41198855

  • Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.

    PubMed 41196655

  • Bayes-Genis A, Cai A, Liu Y, Pandey A, Pop-Busui R, Hansen M, Januzzi JL. Impact of canagliflozin on heart stress and outcomes: Pooled insights from CREDENCE and CANVAS. Eur J Heart Fail. 2025 Dec;27(12):2887-2896. doi: 10.1002/ejhf.3786. Epub 2025 Jul 21.

    PubMed 40689549

  • 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.

    PubMed 40239057

  • 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.

    PubMed 40105285

  • Chatur S, Vaduganathan M, Fletcher RA, Perkovic V, Heerspink H, Arnott C, Pollock C, Mahaffey KW, Neal B, Jardine M, Solomon SD, Neuen BL. Canagliflozin reduces oral loop diuretic intensification in patients with type 2 diabetes: A participant-level pooled analysis of the CANVAS and CREDENCE trials. Eur J Heart Fail. 2025 Jun;27(6):994-1002. doi: 10.1002/ejhf.3586. Epub 2025 Jan 23.

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  • Rasmussen DGK, Hansen MK, Frederiksen P, Luo Y, Pehrsson M, Neal B, Karsdal MA, Genovese F. Association of type III collagen turnover with cardiovascular outcomes and impact with canagliflozin in the CANVAS Program: A post hoc analysis. Diabetes Obes Metab. 2024 Sep;26(9):4060-4068. doi: 10.1111/dom.15761. Epub 2024 Jul 16.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin (JNJ-28431754) 100 mg and Canagliflozin (JNJ-28431754) 300 mg in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Janssen Research & Development, LLC at 305 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 305 sites in United States, India, Australia, Russia, Canada and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke (time frame: Up to approximately 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01032629, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.

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CANVAS - CANagliflozin cardioVascular Assessment Study | AzTrials