Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4330 participants
INTERVENTIONAL
2009-12-09
2017-02-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study
Placebo
One placebo capsule taken orally (by mouth) once daily
Canagliflozin (JNJ-28431754) 100 mg
Each 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
Canagliflozin (JNJ-28431754) 100 mg
One 100 mg capsule taken orally (by mouth) once daily
Canagliflozin (JNJ-28431754) 300 mg
Each 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
Canagliflozin (JNJ-28431754) 300 mg
One 300 mg capsule taken orally (by mouth) once daily
Interventions
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Placebo
One placebo capsule taken orally (by mouth) once daily
Canagliflozin (JNJ-28431754) 100 mg
One 100 mg capsule taken orally (by mouth) once daily
Canagliflozin (JNJ-28431754) 300 mg
One 300 mg capsule taken orally (by mouth) once daily
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6 months before screening
30 Years
ALL
No
Sponsors
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The George Institute for Global Health, Australia
OTHER
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Birmingham, Alabama, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
La Mesa, California, United States
Los Gatos, California, United States
Pismo Beach, California, United States
Stockton, California, United States
Walnut Creek, California, United States
Doral, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Atlanta, Georgia, United States
Duluth, Georgia, United States
Boise, Idaho, United States
Eagle, Idaho, United States
Meridian, Idaho, United States
Peoria, Illinois, United States
Topeka, Kansas, United States
Crestview Hills, Kentucky, United States
Lexington, Kentucky, United States
Auburn, Maine, United States
Scarborough, Maine, United States
Oxon Hill, Maryland, United States
Royal Oak, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Camden, New Jersey, United States
Flushing, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Gallipolis, Ohio, United States
Mentor, Ohio, United States
Toledo, Ohio, United States
Beaver, Pennsylvania, United States
Norristown, Pennsylvania, United States
Sayre, Pennsylvania, United States
Greenville, South Carolina, United States
Kingsport, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Odessa, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Draper, Utah, United States
Salt Lake City, Utah, United States
Sandy City, Utah, United States
West Jordan, Utah, United States
Danville, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Buenos Aires, , Argentina
Capital Federal, , Argentina
Ciudad Autonma Buenos Aires, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
Godoy Cruz, , Argentina
Mar del Plata, , Argentina
Rosario, , Argentina
Santa Fe, , Argentina
Auchenflower, , Australia
Box Hill, , Australia
Caboolture, , Australia
Caringbah, , Australia
Clayton, , Australia
Daw Park, , Australia
East Ringwood, , Australia
Elizabeth Vale, , Australia
Hornsby, Nsw 2077, , Australia
Kippa-Ring, , Australia
Launceston, , Australia
Liverpool, , Australia
Melbourne, , Australia
Milton, , Australia
Parkville, , Australia
Reservoir, , Australia
Sherwood, , Australia
Southport, , Australia
St Leonards, , Australia
West Heidelberg, , Australia
Wollongong, , Australia
Woolloongabba, , Australia
Arlon, , Belgium
Bonheiden, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Genk, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Coquitlam, British Columbia, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Brampton, Ontario, Canada
Greater Sudbury, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Nemarket, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Laval, Quebec, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Val-Bélair, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Bogotá, , Colombia
Floridablanca, , Colombia
Kralupy nad Vltavou, , Czechia
Moravský Krumlov, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Písek, , Czechia
Prague, , Czechia
Znojmo, , Czechia
Pärnu, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Viljandi, , Estonia
Amiens, , France
Nîmes, , France
Pessac, , France
Berlin, , Germany
Dortmund, , Germany
Dresden, , Germany
Hamburg, , Germany
Künzing, , Germany
Mainz, , Germany
Münster, , Germany
Pirna, , Germany
Saarlouis, , Germany
Speyer, , Germany
Villingen-Schwenningen, , Germany
Budapest, , Hungary
Kecskemét, , Hungary
Mosonmagyaróvár, , Hungary
Zalaegerszeg, , Hungary
Ahemadabad, , India
Ahmedabad, , India
Ambawadi, , India
Bangalore, , India
Bangalore, Karnataka, , India
Belagavi, , India
Calicut, , India
Chennai, , India
Coimbatore, , India
Ernākulam, , India
Ghaziabad, , India
Hyderabad, , India
Indore, , India
Jaipur, , India
Karnāl, , India
Kerala, , India
Kochi, , India
Kolkata, , India
Lucknow, , India
Mangalore, , India
Mumbai, , India
Mysore, , India
Nagpur, , India
New Delhi, , India
Patna, , India
Pune, , India
Rajkot, , India
Trivandrum, Kerala, , India
Vadodhara, , India
Vijayawada, , India
Visakhapatnam, , India
Beersheba, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Luxembourg, , Luxembourg
George Town, , Malaysia
Johor Bahru, , Malaysia
Kota Bharu, , Malaysia
Kuala Lumpur, , Malaysia
Petaling Jaya, , Malaysia
Pulau Pinang, , Malaysia
Subang Jaya, , Malaysia
Aguascalientes, , Mexico
Celaya, , Mexico
Durango, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Almelo, , Netherlands
Almere Stad, , Netherlands
Amsterdam, , Netherlands
Arnhem, , Netherlands
Delft, , Netherlands
Den Helder, , Netherlands
Dordrecht, , Netherlands
Eindhoven, , Netherlands
Groningen, , Netherlands
Hoorn, , Netherlands
Rotterdam, , Netherlands
Tilburg, , Netherlands
Utrecht, , Netherlands
Velp Gld, , Netherlands
Zoetermeer, , Netherlands
Zwijndrecht, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Tauranga, , New Zealand
Wellington, , New Zealand
Asker, , Norway
Ålesund, , Norway
Bekkestua, , Norway
Elverum, , Norway
Hamar, , Norway
Lierskogen, , Norway
Moss, , Norway
Oslo, , Norway
Skedsmokorset, , Norway
Bialystok, , Poland
Ciechocinek, , Poland
Gniewkowo, , Poland
Grudziądz, , Poland
Katowice, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Płock, , Poland
Rzeszów, , Poland
Sławków, , Poland
Torun, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Arkhangelsk, , Russia
Chelyabinsk, , Russia
Kemerovo, , Russia
Kirov, , Russia
Kursk, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Penza, , Russia
Rostov-on-Don, , Russia
Russia, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Smolensk, , Russia
Tomsk, , Russia
Tula, , Russia
Tyumen, , Russia
Yaroslavl, , Russia
Yaroslavl Nap, , Russia
Yekaterinburg, , Russia
Alicante, , Spain
Almería, , Spain
Barcelona, , Spain
Figueres, , Spain
Madrid, , Spain
Málaga, , Spain
Oviedo, , Spain
Reus, , Spain
Sabadell, , Spain
Sant Joan d'Alacant, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Viladecans, , Spain
Borås, , Sweden
Gothenburg, , Sweden
Helsingborg, , Sweden
Lund, , Sweden
Malmo, , Sweden
Oskarshamn, , Sweden
Piteå, , Sweden
Stockholm, , Sweden
Uddevalla, , Sweden
Dnipro, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Odesa, , Ukraine
Ternopil, , Ukraine
Uzhhorod, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
Belfast, , United Kingdom
Blackburn, , United Kingdom
Bolton, , United Kingdom
Chorley, , United Kingdom
Derby, , United Kingdom
Glasgow, , United Kingdom
Hull, , United Kingdom
Leicester, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Londonderry, , United Kingdom
Manchester, , United Kingdom
Randalstown, , United Kingdom
Salford, , United Kingdom
York, , United Kingdom
Countries
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References
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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 Jul 21. doi: 10.1002/ejhf.3786. Online ahead of print.
Doi Y, Hamano T, Yamaguchi O, Isaka Y. Canagliflozin may increase thromboembolic events in males with erythrocytosis but not in females. Blood Adv. 2025 Jul 8;9(13):3202-3212. doi: 10.1182/bloodadvances.2025016320.
Nguyen TN, Yu J, Perkovic V, Jardine M, Mahaffey KW, Chow CK, Arnott C, Lindley RI. The Efficacy and Safety of Canagliflozin by Frailty Status in Participants of the CANVAS and CREDENCE Trials. J Am Geriatr Soc. 2025 Jun;73(6):1787-1796. doi: 10.1111/jgs.19444. Epub 2025 Mar 19.
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.
Vaduganathan M, Cannon CP, Jardine MJ, Heerspink HJL, Arnott C, Neuen BL, Sarraju A, Gogate J, Seufert J, Neal B, Perkovic V, Mahaffey KW, Kosiborod MN. Effects of canagliflozin on total heart failure events across the kidney function spectrum: Participant-level pooled analysis from the CANVAS Program and CREDENCE trial. Eur J Heart Fail. 2024 Sep;26(9):1967-1975. doi: 10.1002/ejhf.3292. Epub 2024 Jun 26.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Sharma A, Razaghizad A, Joury A, Levin A, Bajaj HS, Mancini GBJ, Wong NC, Slee A, Ang FG, Rapattoni W, Neuen BL, Arnott C, Perkovic V, Mahaffey KW. Primary and Secondary Cardiovascular and Kidney Prevention With Canagliflozin: Insights From the CANVAS Program and CREDENCE Trial. J Am Heart Assoc. 2024 Feb 6;13(3):e031586. doi: 10.1161/JAHA.123.031586. Epub 2024 Jan 19.
Yu J, Sweeting AN, Gianacas C, Houston L, Lee V, Fletcher RA, Perkovic V, Li Q, Neuen BL, Berwanger O, Heerspink HJL, de Zeeuw D, Arnott C. The effects of canagliflozin in type 2 diabetes in subgroups defined by population-specific body mass index: Insights from the CANVAS Program and CREDENCE trial. Diabetes Obes Metab. 2023 Dec;25(12):3724-3735. doi: 10.1111/dom.15267. Epub 2023 Sep 6.
Sen T, Ju W, Nair V, Ladd P, Menon R, Otto EA, Pyle L, Vigers T, Nelson RG, Arnott C, Neal B, Hansen MK, Kretzler M, Bjornstad P, Heerspink HJL. Sodium glucose co-transporter 2 inhibition increases epidermal growth factor expression and improves outcomes in patients with type 2 diabetes. Kidney Int. 2023 Oct;104(4):828-839. doi: 10.1016/j.kint.2023.07.007. Epub 2023 Aug 4.
Fletcher RA, Arnott C, Rockenschaub P, Schutte AE, Carpenter L, Vaduganathan M, Agarwal R, Bakris G, Chang TI, Heerspink HJL, Jardine MJ, Mahaffey KW, Neal B, Pollock C, Jun M, Rodgers A, Perkovic V, Neuen BL. Canagliflozin, Blood Pressure Variability, and Risk of Cardiovascular, Kidney, and Mortality Outcomes: Pooled Individual Participant Data From the CANVAS and CREDENCE Trials. J Am Heart Assoc. 2023 Jul 4;12(13):e028516. doi: 10.1161/JAHA.122.028516. Epub 2023 Jun 22.
Borisov AN, Kutz A, Christ ER, Heim MH, Ebrahimi F. Canagliflozin and Metabolic Associated Fatty Liver Disease in Patients With Diabetes Mellitus: New Insights From CANVAS. J Clin Endocrinol Metab. 2023 Oct 18;108(11):2940-2949. doi: 10.1210/clinem/dgad249.
Ferrannini G, Pollock C, Natali A, Yavin Y, Mahaffey KW, Ferrannini E. Extremes of both weight gain and weight loss are associated with increased incidence of heart failure and cardiovascular death: evidence from the CANVAS Program and CREDENCE. Cardiovasc Diabetol. 2023 Apr 29;22(1):100. doi: 10.1186/s12933-023-01832-5.
Rasmussen DGK, Hansen MK, Blair J, Jatkoe TA, Neal B, Karsdal MA, Genovese F. Endotrophin is a risk marker of complications in CANagliflozin cardioVascular Assessment Study (CANVAS): a randomized controlled trial. Cardiovasc Diabetol. 2022 Nov 28;21(1):261. doi: 10.1186/s12933-022-01666-7.
Nunes JC, Yu J, Arnott C, Jardine MJ, Perkovic V, Mahaffey KW. Canagliflozin, mental health adverse events and diabetes: Exploratory analysis of the CREDENCE trial and CANVAS Program. Diabetes Obes Metab. 2022 Dec;24(12):2459-2464. doi: 10.1111/dom.14832. Epub 2022 Aug 19. No abstract available.
Ferrannini E, Baldi S, Scozzaro T, Tsimihodimos V, Tesfaye F, Shaw W, Rosenthal N, Figtree GA, Neal B, Mahaffey KW, Perkovic V, Hansen MK. Fasting Substrate Concentrations Predict Cardiovascular Outcomes in the CANagliflozin cardioVascular Assessment Study (CANVAS). Diabetes Care. 2022 Aug 1;45(8):1893-1899. doi: 10.2337/dc21-2398.
Vaduganathan M, Sattar N, Xu J, Butler J, Mahaffey KW, Neal B, Shaw W, Rosenthal N, Pfeifer M, Hansen MK, Januzzi JL Jr. Stress Cardiac Biomarkers, Cardiovascular and Renal Outcomes, and Response to Canagliflozin. J Am Coll Cardiol. 2022 Feb 8;79(5):432-444. doi: 10.1016/j.jacc.2021.11.027.
Waijer SW, Sen T, Arnott C, Neal B, Kosterink JGW, Mahaffey KW, Parikh CR, de Zeeuw D, Perkovic V, Neuen BL, Coca SG, Hansen MK, Gansevoort RT, Heerspink HJL. Association between TNF Receptors and KIM-1 with Kidney Outcomes in Early-Stage Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2022 Feb;17(2):251-259. doi: 10.2215/CJN.08780621. Epub 2021 Dec 7.
Young TK, Li JW, Kang A, Heerspink HJL, Hockham C, Arnott C, Neuen BL, Zoungas S, Mahaffey KW, Perkovic V, de Zeeuw D, Fulcher G, Neal B, Jardine M. Effects of canagliflozin compared with placebo on major adverse cardiovascular and kidney events in patient groups with different baseline levels of HbA1c, disease duration and treatment intensity: results from the CANVAS Program. Diabetologia. 2021 Nov;64(11):2402-2414. doi: 10.1007/s00125-021-05524-1. Epub 2021 Aug 26.
Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.
Yu J, Arnott C, Neuen BL, Heersprink HL, Mahaffey KW, Cannon CP, Khan SS, Baldridge AS, Shah SJ, Huang Y, Li C, Figtree GA, Perkovic V, Jardine MJ, Neal B, Huffman MD. Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program. ESC Heart Fail. 2021 Apr;8(2):1482-1493. doi: 10.1002/ehf2.13236. Epub 2021 Feb 17.
Januzzi JL Jr, Butler J, Sattar N, Xu J, Shaw W, Rosenthal N, Pfeifer M, Mahaffey KW, Neal B, Hansen MK. Insulin-Like Growth Factor Binding Protein 7 Predicts Renal and Cardiovascular Outcomes in the Canagliflozin Cardiovascular Assessment Study. Diabetes Care. 2021 Jan;44(1):210-216. doi: 10.2337/dc20-1889. Epub 2020 Nov 6.
Januzzi JL Jr, Xu J, Li J, Shaw W, Oh R, Pfeifer M, Butler J, Sattar N, Mahaffey KW, Neal B, Hansen MK. Effects of Canagliflozin on Amino-Terminal Pro-B-Type Natriuretic Peptide: Implications for Cardiovascular Risk Reduction. J Am Coll Cardiol. 2020 Nov 3;76(18):2076-2085. doi: 10.1016/j.jacc.2020.09.004.
Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Blais J, Li Q, Jardine MJ, Perkovic V, Wheeler DC. Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program. Am J Kidney Dis. 2021 Jan;77(1):23-34.e1. doi: 10.1053/j.ajkd.2020.06.018. Epub 2020 Sep 21.
Oshima M, Neal B, Toyama T, Ohkuma T, Li Q, de Zeeuw D, Heerspink HJL, Mahaffey KW, Fulcher G, Canovatchel W, Matthews DR, Perkovic V. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program. J Am Soc Nephrol. 2020 Oct;31(10):2446-2456. doi: 10.1681/ASN.2019121312. Epub 2020 Jul 21.
Matthews DR, Wysham C, Davies M, Slee A, Alba M, Lee M, Perkovic V, Mahaffey KW, Neal B. Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program. Diabetes Obes Metab. 2020 Nov;22(11):2199-2203. doi: 10.1111/dom.14143. Epub 2020 Aug 24.
Zhou Z, Jardine M, Perkovic V, Matthews DR, Mahaffey KW, de Zeeuw D, Fulcher G, Desai M, Oh R, Simpson R, Watts NB, Neal B. Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program. Diabetologia. 2019 Oct;62(10):1854-1867. doi: 10.1007/s00125-019-4955-5. Epub 2019 Aug 10.
Figtree GA, Radholm K, Barrett TD, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Neal B. Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2591-2593. doi: 10.1161/CIRCULATIONAHA.119.040057. Epub 2019 Mar 17. No abstract available.
Zhou Z, Lindley RI, Radholm K, Jenkins B, Watson J, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Shaw W, Oh R, Desai M, Matthews DR, Neal B. Canagliflozin and Stroke in Type 2 Diabetes Mellitus. Stroke. 2019 Feb;50(2):396-404. doi: 10.1161/STROKEAHA.118.023009.
Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Desai M, Li Q, Deng H, Rosenthal N, Jardine MJ, Bakris G, Perkovic V. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation. 2018 Oct 9;138(15):1537-1550. doi: 10.1161/CIRCULATIONAHA.118.035901.
Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21.
Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.
Radholm K, Figtree G, Perkovic V, Solomon SD, Mahaffey KW, de Zeeuw D, Fulcher G, Barrett TD, Shaw W, Desai M, Matthews DR, Neal B. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation. 2018 Jul 31;138(5):458-468. doi: 10.1161/CIRCULATIONAHA.118.034222.
Mahaffey KW, Neal B, Perkovic V, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Fabbrini E, Sun T, Li Q, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018 Jan 23;137(4):323-334. doi: 10.1161/CIRCULATIONAHA.117.032038. Epub 2017 Nov 13.
Yale JF, Xie J, Sherman SE, Garceau C. Canagliflozin in Conjunction With Sulfonylurea Maintains Glycemic Control and Weight Loss Over 52 Weeks: A Randomized, Controlled Trial in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2017 Nov;39(11):2230-2242.e2. doi: 10.1016/j.clinthera.2017.10.003. Epub 2017 Nov 3.
Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.
Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.
Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.
Fulcher G, Matthews DR, Perkovic V, de Zeeuw D, Mahaffey KW, Weiss R, Rosenstock J, Capuano G, Desai M, Shaw W, Vercruysse F, Meininger G, Neal B. Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial. Diabetes Ther. 2015 Sep;6(3):289-302. doi: 10.1007/s13300-015-0117-z. Epub 2015 Jun 17.
Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Ways K, Desai M, Shaw W, Capuano G, Alba M, Jiang J, Vercruysse F, Meininger G, Matthews D; CANVAS Trial Collaborative Group. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):403-11. doi: 10.2337/dc14-1237. Epub 2014 Dec 2.
Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.
Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.
Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Stein P, Desai M, Shaw W, Jiang J, Vercruysse F, Meininger G, Matthews D. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial. Am Heart J. 2013 Aug;166(2):217-223.e11. doi: 10.1016/j.ahj.2013.05.007. Epub 2013 Jun 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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28431754DIA3008
Identifier Type: OTHER
Identifier Source: secondary_id
2009-012140-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR016627
Identifier Type: -
Identifier Source: org_study_id
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