AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4CANVAS-RNCT01989754

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

A Phase 4 study testing Canagliflozin, 100 mg and Canagliflozin, 300 mg in people with Diabetes Mellitus, Type 2 and Albuminuria, run by Janssen Research & Development, LLC at 341 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 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Diabetes Mellitus, Type 2, Albuminuria
What is being tested?
Canagliflozin, 100 mg and Canagliflozin, 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,813 participants
Where
341 sitesin 25 countries
Study dates
16 Jan 2014to 23 Feb 2017
Phase
Phase 4
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

341 sites in 25 countries.

341 sites in 25 countries

United States57 sites

  • Study site

    Austin, Texas

  • Study site

    Beaver, Pennsylvania

  • Study site

    Bountiful, Utah

  • Study site

    Canal Fulton, Ohio

  • Study site

    Carmichael, California

  • Study site

    Chicago, Illinois

  • Study site

    Concord, California

  • Study site

    Cornelius, North Carolina

  • Study site

    Denver, Colorado

  • Study site

    Draper, Utah

  • Study site

    Elkridge, Maryland

  • Study site

    Falls Church, Virginia

  • Study site

    Flint, Michigan

  • Study site

    Franklin, Ohio

  • Study site

    Greer, South Carolina

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Jacksonville, Florida

  • Study site

    Jefferson City, Tennessee

  • Study site

    Kansas City, Missouri

  • Study site

    Las Vegas, Nevada

  • Study site

    Levittown, Pennsylvania

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    Mandeville, Louisiana

  • Study site

    Mason, Ohio

  • Study site

    Meridian, Idaho

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mooresville, North Carolina

  • Study site

    New Port Richey, Florida

  • Study site

    Norfolk, Virginia

  • Study site

    Norristown, Pennsylvania

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Opa-locka, Florida

  • Study site

    Orlando, Florida

  • Study site

    Palm Harbor, Florida

  • Study site

    Pearland, Texas

  • Study site

    Picayune, Mississippi

  • Study site

    Pismo Beach, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Roseville, California

  • Study site

    Salt Lake City, Utah

  • Study site

    South Burlington, Vermont

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Thousand Oaks, California

  • Study site

    Tipton, Pennsylvania

  • Study site

    Topeka, Kansas

  • Study site

    Valparaiso, Indiana

  • Study site

    Virginia Beach, Virginia

  • Study site

    Washington, Missouri

  • Study site

    Wauwatosa, Wisconsin

  • Study site

    West Jordan, Utah

Other trials in United States

Spain24 sites

  • Study site

    A Coruña

  • Study site

    Alcalá de Henares

  • Study site

    Alicante

  • Study site

    Almería

  • Study site

    Alzira

  • Study site

    Barcelona

  • Study site

    Ciudad Real

  • Study site

    Córdoba

  • Study site

    Ferrol

  • Study site

    Figueres

  • Study site

    Galdakao

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Móstoles

  • Study site

    Palma de Mallorca

  • Study site

    Sabadell

  • Study site

    San Sebastián de los Reyes

  • Study site

    Sant Joan d'Alacant

  • Study site

    Santa Cruz de Tenerife

  • Study site

    Santiago de Compostela

  • Study site

    Segovia

  • Study site

    Seville

  • Study site

    Valencia

  • Study site

    Viladecans

Other trials in Spain

Netherlands21 sites

  • Study site

    Almelo

  • Study site

    Almere Stad

  • Study site

    Amersfoort

  • Study site

    Amsterdam

  • Study site

    Dordrecht

  • Study site

    Eindhoven

  • Study site

    Groningen

  • Study site

    Hardenberg

  • Study site

    Hoogeveen

  • Study site

    Hoogezand

  • Study site

    Kloosterhaar

  • Study site

    Leiden

  • Study site

    Meppel

  • Study site

    Poortvliet

  • Study site

    Rotterdam

  • Study site

    Utrecht

  • Study site

    Velp

  • Study site

    Waalwijk

  • Study site

    Wamel

  • Study site

    Zoetermeer

  • Study site

    Zwijndrecht

Other trials in Netherlands

United Kingdom19 sites

  • Study site

    Addlestone

  • Study site

    Belfast

  • Study site

    Birmingham

  • Study site

    Blackburn

  • Study site

    Bristol

  • Study site

    Bury St Edmunds

  • Study site

    Chesterfield

  • Study site

    Derby

  • Study site

    Doncaster

  • Study site

    Ipswich

  • Study site

    Leicester

  • Study site

    Liverpool

  • Study site

    Manchester

  • Study site

    Salford

  • Study site

    Taunton

  • Study site

    Torquay

  • Study site

    Truro

  • Study site

    Wellingborough

  • Study site

    Welwyn Garden City

Other trials in United Kingdom

Ukraine17 sites

  • Study site

    Cherkasy

  • Study site

    Chernivtsy

  • Study site

    Dnipropetrovsk

  • Study site

    Ivan-Frankivsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Canada16 sites

  • Study site

    Coquitlam, British Columbia

  • Study site

    Guelph, Ontario

  • Study site

    Halifax, Nova Scotia

  • Study site

    Laval, Quebec

  • Study site

    Lévis, Quebec

  • Study site

    Mississauga, Ontario

  • Study site

    Oshawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Saint Marc Des Carriéres, Quebec

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Sherbrooke, Quebec

  • Study site

    Thornhill, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Westmont, Quebec

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Russia15 sites

  • Study site

    Arkhangelsk

  • Study site

    Barnaul

  • Study site

    Chelyabinsk

  • Study site

    Kemerovo

  • Study site

    Nizhny Novgorod

  • Study site

    Penza

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

  • Study site

    Smolensk

  • Study site

    Syktyvkar

  • Study site

    Tyumen

  • Study site

    Vsevolzhsk

  • Study site

    Yaroslavl

Other trials in Russia

South Korea15 sites

  • Study site

    Ansan

  • Study site

    Bucheon-si

  • Study site

    Busan

  • Study site

    Changwon

  • Study site

    Cheongju-si

  • Study site

    Daegu

  • Study site

    Gyeonggi-do

  • Study site

    Iksan

  • Study site

    Incheon

  • Study site

    Jeonju

  • Study site

    Seongnam-si

  • Study site

    Seoul

  • Study site

    Suwon

  • Study site

    Ulsan

  • Study site

    Wŏnju

Other trials in South Korea

Italy13 sites

  • Study site

    *Osenza*

  • Study site

    Arenzano

  • Study site

    Bologna

  • Study site

    Catanzaro

  • Study site

    Chieri (Torino)

  • Study site

    Florence

  • Study site

    Messina

  • Study site

    Milan

  • Study site

    Naples

  • Study site

    Ravenna

  • Study site

    Roma

  • Study site

    Sesto San Giovanni (Milano)

  • Study site

    Verona

Other trials in Italy

Poland13 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Chrzanów

  • Study site

    Gdansk

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Oświęcim

  • Study site

    Torun

  • Study site

    Tychy

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Australia12 sites

  • Study site

    Box Hill

  • Study site

    Cairns

  • Study site

    Daw Park

  • Study site

    Freemantle

  • Study site

    Liverpool

  • Study site

    Melbourne

  • Study site

    Newcastle

  • Study site

    Sherwood

  • Study site

    Sydney

  • Study site

    Tasmania

  • Study site

    Woden

  • Study site

    Woolloongabba

Other trials in Australia

Belgium12 sites

  • Study site

    Bonheiden

  • Study site

    Bruges

  • Study site

    Edegem

  • Study site

    Ghent

  • Study site

    La Louvière

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Liÿge

  • Study site

    Merksem

  • Study site

    Ransart

  • Study site

    Roeselare

  • Study site

    Tessenderlo

Other trials in Belgium

Brazil12 sites

  • Study site

    Belém

  • Study site

    Belo Horizonte

  • Study site

    Campinas

  • Study site

    Caxias do Sul

  • Study site

    Curitiba

  • Study site

    Fortaleza

  • Study site

    Mogi das Cruzes

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

Other trials in Brazil

Germany12 sites

  • Study site

    Aschaffenburg

  • Study site

    Aßlar

  • Study site

    Bad Oeynhausen

  • Study site

    Dortmund

  • Study site

    Dresden

  • Study site

    Freiburg im Breisgau

  • Study site

    Hanover

  • Study site

    Kassel

  • Study site

    Mainz

  • Study site

    Neuwied

  • Study site

    Saarbrücken

  • Study site

    Villingen-Schwenningen

Other trials in Germany

Sweden12 sites

  • Study site

    Borås

  • Study site

    Gothenburg

  • Study site

    Helsingborg

  • Study site

    Karlstad

  • Study site

    Linköping

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Stockholm

  • Study site

    Uddevalla

  • Study site

    Uppsala

  • Study site

    Vällingby

  • Study site

    Västra Frölunda

Other trials in Sweden

Hungary11 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Dunaújváros

  • Study site

    Eger

  • Study site

    Kecskemét

  • Study site

    Nagykanizsa

  • Study site

    Pécs

  • Study site

    Székesfehérvár

  • Study site

    Szikszó

  • Study site

    Szombathely

  • Study site

    Zalaegerszeg

Other trials in Hungary

France10 sites

  • Study site

    Amiens

  • Study site

    Bois-Guillaume

  • Study site

    Bordeaux

  • Study site

    Dijon

  • Study site

    Grenoble

  • Study site

    La Rochelle

  • Study site

    Le Creusot

  • Study site

    Narbonne

  • Study site

    Paris

  • Study site

    Poitiers

Other trials in France

Mexico10 sites

  • Study site

    Aguascalientes

  • Study site

    Celaya

  • Study site

    Cuernavaca

  • Study site

    Culiacán

  • Study site

    Guadalajara

  • Study site

    México

  • Study site

    Pachuca

  • Study site

    Querétaro

  • Study site

    San Luis Potosí City

  • Study site

    Tampico

Other trials in Mexico

Argentina7 sites

  • Study site

    Buenos Aires

  • Study site

    Ciudad de Buenos Aires

  • Study site

    Córdoba

  • Study site

    Mar del Plata

  • Study site

    Morón

  • Study site

    Rosario

  • Study site

    Zarate, Buenos Aires

Other trials in Argentina

Malaysia7 sites

  • Study site

    Batu Caves

  • Study site

    George Town

  • Study site

    Ipoh

  • Study site

    Kelantan

  • Study site

    Kota Bharu

  • Study site

    Kuala Lumpur

  • Study site

    Kuching

Other trials in Malaysia

New Zealand7 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Newtown

  • Study site

    Palmerston North

  • Study site

    Rotorua

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

China6 sites

  • Study site

    Baotou

  • Study site

    Beijing

  • Study site

    Hangzhou

  • Study site

    Jinan

  • Study site

    Shenyang

  • Study site

    Wuxi

Other trials in China

Taiwan6 sites

  • Study site

    Kaohsiung County

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Tiachung

  • Study site

    Xindian

Other trials in Taiwan

Czechia5 sites

  • Study site

    Beroun

  • Study site

    Ostrava

  • Study site

    Pilsen

  • Study site

    Prague

  • Study site

    Znojmo

Other trials in Czechia

Puerto Rico2 sites

  • Study site

    Ponce Pr

  • Study site

    Trujillo Alto

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
Placebo, Canagliflozin, 100 mg, Canagliflozin, 300 mg
Keywords
Albuminuria, Canagliflozin, Cardiovascular outcomes, Type 2 Diabetes Mellitus, T2DM, JNJ-28431754, Antihyperglycemic Agent
Medical subject headings
Diabetes Mellitus, Type 2, Albuminuria

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 for 156 weeks

  • Canagliflozin, 100 mgDrug

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

  • Canagliflozin, 300 mgDrug

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

Study groups in NCT01989754
Study groupRoleWhat they receive
Canagliflozin (JNJ-28431754)ExperimentalEach patient will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 13 weeks, then the dose may be increased to 300 mg once daily.
Receives: Drug: Canagliflozin, 100 mg; Drug: Canagliflozin, 300 mg
PlaceboPlacebo comparatorEach patient will receive placebo (inactive medication) once daily.
Receives: Drug: Placebo

What is being measured

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

  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.

    Measured: Up to 3 years

Secondary outcomes (2)

  1. Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure

    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.

    Measured: Approximately 3 years

  2. Cardiovascular (CV) Death

    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.

    Measured: Approximately 3 years

Timeline

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

  1. First posted21 Nov 2013 (estimated)
  2. Study start16 Jan 2014
  3. Primary completion23 Feb 2017
  4. Study completion23 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,813 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989754
Sponsor's protocol ID
CR102647
Other IDs
2013-003050-25, 28431754DIA4003
Acronym
CANVAS-R
Status last verified
Nov 2018
First submitted
17 Oct 2013
Last updated
11 Dec 2018
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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

  • 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.

    PubMed 40375260

  • 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

  • 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.

    PubMed 38932575

  • Tangri N, Ferguson TW, Bamforth RJ, Leon SJ, Arnott C, Mahaffey KW, Kotwal S, Heerspink HJL, Perkovic V, Fletcher RA, Neuen BL. Machine learning for prediction of chronic kidney disease progression: Validation of the Klinrisk model in the CANVAS Program and CREDENCE trial. Diabetes Obes Metab. 2024 Aug;26(8):3371-3380. doi: 10.1111/dom.15678. Epub 2024 May 28.

    PubMed 38807510

  • 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.

    PubMed 38770818

  • 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.

    PubMed 38240199

  • 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.

    PubMed 37671609

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Canagliflozin, 100 mg and Canagliflozin, 300 mg in people with Diabetes Mellitus, Type 2 and Albuminuria, run by Janssen Research & Development, LLC at 341 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 4 inclusion and 6 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 11 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 341 sites in United States, Spain, Netherlands, United Kingdom, Ukraine 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 11 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?

Progression of Albuminuria (time frame: Up to 3 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 NCT01989754, which also lists 29 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 11 Dec 2018.

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