The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
NCT ID: NCT01106625
Last Updated: 2013-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
469 participants
INTERVENTIONAL
2010-05-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Metformin
The patient's stable dose of background metformin therapy should be continued throughout the study.
Sulphonylruea
The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Metformin
The patient's stable dose of background metformin therapy should be continued throughout the study.
Sulphonylruea
The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Placebo
Each patient will receive matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Placebo
One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Metformin
The patient's stable dose of background metformin therapy should be continued throughout the study.
Sulphonylruea
The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Interventions
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Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Placebo
One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Metformin
The patient's stable dose of background metformin therapy should be continued throughout the study.
Sulphonylruea
The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Eligibility Criteria
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Inclusion Criteria
* Patients in the study must have a HbA1c between \>=7 and \<=10.5%
* Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC C. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Huntsville, Alabama, United States
Little Rock, Alaska, United States
Phoenix, Arizona, United States
Chino, California, United States
Fair Oaks, California, United States
Roseville, California, United States
Wes Hills, California, United States
Waterbury, Connecticut, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Augusta, Georgia, United States
Roswell, Georgia, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Reisterstown, Maryland, United States
Olive Branch, Mississippi, United States
St Louis, Missouri, United States
Westfield, New York, United States
Greenville, North Carolina, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Altoona, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Levittown, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Greer, South Carolina, United States
Bryan, Texas, United States
Dallas, Texas, United States
DeSoto, Texas, United States
Salt Lake City, Utah, United States
South Burlington, Vermont, United States
Wenatchee, Washington, United States
Freemantle, , Australia
Heidelberg Heights, , Australia
Meadowbrook, , Australia
Nedlands, , Australia
Wollongong, , Australia
Aalst, , Belgium
Bonheiden, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Corbeil-Essonnes, , France
La Rochelle, , France
Le Creusot, , France
Poitiers, , France
Vénissieux, , France
Guatemala City, , Guatemala
Balatonfüred, , Hungary
Budapest, , Hungary
Győr, , Hungary
Zalaegerszeg, , Hungary
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Tel Aviv, , Israel
Guadalajara, , Mexico
Monterrey, , Mexico
Carolina, , Puerto Rico
Trujillo Alto, , Puerto Rico
Arkhangelsk, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Alicante, , Spain
Almería, , Spain
Málaga, , Spain
Seville, , Spain
Valencia, , Spain
Belfast, , United Kingdom
Bolton, , United Kingdom
Liverpool, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.
Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.
Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.
Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.
Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.
John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.
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.
Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.
Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.
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.
Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.
Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.
Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.
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.
Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.
Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.
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.
Other Identifiers
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28431754DIA3002
Identifier Type: OTHER
Identifier Source: secondary_id
CR017005
Identifier Type: -
Identifier Source: org_study_id
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