The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)
NCT ID: NCT01106677
Last Updated: 2013-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1284 participants
INTERVENTIONAL
2010-05-31
2012-05-31
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 immediate release.
Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Metformin immediate release
The patient's stable dose of metformin immediate release background 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 immediate release.
Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Metformin immediate release
The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.
Sitagliptin 100 mg
Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Sitagliptin
One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.
Metformin immediate release
The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.
Placebo/Sitagliptin
Each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin will be given with protocol-specified doses of metformin immediate release.
Placebo
One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.
Sitagliptin
One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.
Metformin immediate release
The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.
Interventions
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Placebo
One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.
Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Sitagliptin
One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.
Metformin immediate release
The patient's stable dose of metformin immediate release background 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 Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Little Rock, Arkansas, United States
Fountain Valley, California, United States
National City, California, United States
Northridge, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
DeFuniak Springs, Florida, United States
Hialeah, Florida, United States
Niceville, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Champaign, Illinois, United States
Avon, Indiana, United States
Fishers, Indiana, United States
Franklin, Indiana, United States
West Des Moines, Iowa, United States
Wichita, Kansas, United States
Munfordville, Kentucky, United States
Portland, Maine, United States
Benzonia, Michigan, United States
Interlochen, Michigan, United States
Troy, Michigan, United States
Picayune, Mississippi, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Mansfield, New Jersey, United States
New Hyde Park, New York, United States
Asheboro, North Carolina, United States
Charlotte, North Carolina, United States
Kettering, Ohio, United States
Oregon City, Oregon, United States
Altoona, Pennsylvania, United States
Tipton, Pennsylvania, United States
East Providence, Rhode Island, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Nashville, Tennessee, United States
New Braunfels, Texas, United States
San Antonio, Texas, United States
Bountiful, Utah, United States
Spokane, Washington, United States
Buenos Aires, , Argentina
Mendoza, , Argentina
San Juan, , Argentina
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Barranquilla, , Colombia
Bogotá, , Colombia
Medellín, , Colombia
Beroun, , Czechia
Pardubice, , Czechia
Pilsen, , Czechia
Rychnov nad Kněžnou, , Czechia
Tábor, , Czechia
Tallinn, , Estonia
Piraeus, , Greece
Thessalonikis, , Greece
Ahmedabad, Gujarat, , India
Aurangabad, , India
Bangalore, , India
Bangalore, Karnataka, , India
Belagavi, , India
Coimbatore, , India
Mumbai, , India
Nagpur, , India
Pune, , India
Trivandrum, , India
Daugavpils, , Latvia
Limbaži, , Latvia
Riga, , Latvia
Talsi, , Latvia
Kelantan, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Selangor, , Malaysia
Pulau Pinang, , Malaysia
Culiacán, , Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
Querétaro, , Mexico
Tampico, , Mexico
Lima 1 Lima Lima, , Peru
Lodz, , Poland
Lublin, , Poland
Wroclaw, , Poland
Zgierz, , Poland
Łęczyca, , Poland
Aveiro, , Portugal
Leiria, , Portugal
Lisbon, , Portugal
Portalegre, , Portugal
San Juan, , Puerto Rico
Chelyabinsk, , Russia
Dzerzhinsky Moscow Region, , Russia
Kemerovo, , Russia
Penza, , Russia
Saint Petersburg, , Russia
Yekaterinburg, , Russia
Singapore, , Singapore
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Šahy, , Slovakia
Trebišov, , Slovakia
Gothenburg, , Sweden
Stockholm, , Sweden
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Ankara, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kiev, , Ukraine
Sumy, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
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.
Schernthaner G, Lavalle-Gonzalez FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. doi: 10.1080/00325481.2016.1210988. Epub 2016 Jul 26.
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.
Bailey RA, Vijapurkar U, Meininger G, Rupnow MF, Blonde L. Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials. Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.
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.
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.
Lavalle-Gonzalez FJ, Januszewicz A, Davidson J, Tong C, Qiu R, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013 Dec;56(12):2582-92. doi: 10.1007/s00125-013-3039-1. Epub 2013 Sep 13.
Other Identifiers
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28431754DIA3006
Identifier Type: OTHER
Identifier Source: secondary_id
CR017023
Identifier Type: -
Identifier Source: org_study_id
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