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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01032629




Registration number
NCT01032629
Ethics application status
Date submitted
10/12/2009
Date registered
15/12/2009
Date last updated
7/12/2018

Titles & IDs
Public title
CANVAS - CANagliflozin cardioVascular Assessment Study
Scientific 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
Secondary ID [1] 0 0
28431754DIA3008
Secondary ID [2] 0 0
CR016627
Universal Trial Number (UTN)
Trial acronym
CANVAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Cardiovascular Diseases 0 0
Risk Factors 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Canagliflozin (JNJ-28431754) 100 mg
Treatment: Drugs - Canagliflozin (JNJ-28431754) 300 mg

Placebo comparator: Placebo - Each patient will receive placebo (inactive medication) on background standard of care for diabetes once daily for the duration of the study

Experimental: 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

Experimental: 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


Treatment: Drugs: Placebo
One placebo capsule taken orally (by mouth) once daily

Treatment: Drugs: Canagliflozin (JNJ-28431754) 100 mg
One 100 mg capsule taken orally (by mouth) once daily

Treatment: Drugs: Canagliflozin (JNJ-28431754) 300 mg
One 300 mg capsule taken orally (by mouth) once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
Timepoint [1] 0 0
Up to approximately 8 years
Secondary outcome [1] 0 0
Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)
Timepoint [1] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [2] 0 0
Percentage of Participants With Progression of Albuminuria at the End-of-Treatment
Timepoint [2] 0 0
End of treatment (approximately 338 weeks)
Secondary outcome [3] 0 0
Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment
Timepoint [3] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [4] 0 0
Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment
Timepoint [4] 0 0
Baseline and End of treatment (approximately 338 weeks)
Secondary outcome [5] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment
Timepoint [5] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [6] 0 0
Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment
Timepoint [6] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [7] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment
Timepoint [7] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [8] 0 0
Percent Change From Baseline in Body Weight at End-of-Treatment
Timepoint [8] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [9] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment
Timepoint [9] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [10] 0 0
Change From Baseline in Triglycerides Levels at End-of-Treatment
Timepoint [10] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [11] 0 0
Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment
Timepoint [11] 0 0
Baseline and end of treatment (approximately 338 weeks)
Secondary outcome [12] 0 0
Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment
Timepoint [12] 0 0
Baseline and end of treatment (approximately 338 weeks)

Eligibility
Key inclusion criteria
* 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
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2017
Sample size
Target
Accrual to date
Final
4330
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Auchenflower
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Caboolture
Recruitment hospital [4] 0 0
- Caringbah
Recruitment hospital [5] 0 0
- Clayton
Recruitment hospital [6] 0 0
- Daw Park
Recruitment hospital [7] 0 0
- East Ringwood
Recruitment hospital [8] 0 0
- Elizabeth Vale
Recruitment hospital [9] 0 0
- Hornsby, Nsw 2077
Recruitment hospital [10] 0 0
- Kippa Ring
Recruitment hospital [11] 0 0
- Launceston
Recruitment hospital [12] 0 0
- Liverpool
Recruitment hospital [13] 0 0
- Melbourne
Recruitment hospital [14] 0 0
- Milton
Recruitment hospital [15] 0 0
- Parkville
Recruitment hospital [16] 0 0
- Reservoir
Recruitment hospital [17] 0 0
- Sherwood
Recruitment hospital [18] 0 0
- Southport
Recruitment hospital [19] 0 0
- St Leonards
Recruitment hospital [20] 0 0
- West Heidelberg
Recruitment hospital [21] 0 0
- Wollongong
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- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Auchenflower
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- Box Hill
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- Caboolture
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- Caringbah
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- Clayton
Recruitment postcode(s) [6] 0 0
- Daw Park
Recruitment postcode(s) [7] 0 0
- East Ringwood
Recruitment postcode(s) [8] 0 0
- Elizabeth Vale
Recruitment postcode(s) [9] 0 0
- Hornsby, Nsw 2077
Recruitment postcode(s) [10] 0 0
- Kippa Ring
Recruitment postcode(s) [11] 0 0
- Launceston
Recruitment postcode(s) [12] 0 0
- Liverpool
Recruitment postcode(s) [13] 0 0
- Melbourne
Recruitment postcode(s) [14] 0 0
- Milton
Recruitment postcode(s) [15] 0 0
- Parkville
Recruitment postcode(s) [16] 0 0
- Reservoir
Recruitment postcode(s) [17] 0 0
- Sherwood
Recruitment postcode(s) [18] 0 0
- Southport
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- St Leonards
Recruitment postcode(s) [20] 0 0
- West Heidelberg
Recruitment postcode(s) [21] 0 0
- Wollongong
Recruitment postcode(s) [22] 0 0
- Woolloongabba
Recruitment outside Australia
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Plock
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Poznan
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Rzeszow
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Slawkow
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Torun
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Warszawa
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Wroclaw
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Arkhangelsk
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Chelyabinsk
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Ekaterinburg
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Kemerovo
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Kirov
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Kursk
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Moscow N/A
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Moscow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute for Global Health, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/study/NCT01032629
Trial related presentations / publications
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. Erratum In: ESC Heart Fail. 2021 Aug;8(4):3447. doi: 10.1002/ehf2.13408.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01032629