The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
NCT ID: NCT01137812
Last Updated: 2015-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
756 participants
INTERVENTIONAL
2010-07-31
2012-03-31
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 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Canagliflozin 300 mg
One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Metformin
Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Sulphonylurea
Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Sitagliptin 100 mg
Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Sitagliptin 100 mg
One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Metformin
Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Sulphonylurea
Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Interventions
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Sitagliptin 100 mg
One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Canagliflozin 300 mg
One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Metformin
Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Sulphonylurea
Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Eligibility Criteria
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Inclusion Criteria
* Patients in the study must have a HbA1c between \>=7 and \<=10.5% and a fasting plasma glucose (FPG) \<300 mg/dL (16.7 mmol/L)
Exclusion Criteria
* or a severe hypoglycemic episode within 6 months before screening
18 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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Mobile, Alabama, United States
Goodyear, Arizona, United States
Mesa, Arizona, United States
Escondido, California, United States
Fresno, California, United States
Greenbrae, California, United States
La Mesa, California, United States
Laguna Hills, California, United States
Lancaster, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Norwalk, California, United States
Pismo Beach, California, United States
Roseville, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Watsonville, California, United States
Denver, Colorado, United States
Northglenn, Colorado, United States
Milford, Connecticut, United States
Bradenton, Florida, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Delray Beach, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Lewiston, Idaho, United States
Chicago, Illinois, United States
O'Fallon, Illinois, United States
Springfield, Illinois, United States
Topeka, Kansas, United States
Bowling Green, Kentucky, United States
Lexington, Kentucky, United States
Madisonville, Kentucky, United States
Baton Rouge, Louisiana, United States
Mandeville, Louisiana, United States
Metairie, Louisiana, United States
Sunset, Louisiana, United States
Brockton, Massachusetts, United States
Saint Clair Shores, Michigan, United States
Southfield, Michigan, United States
Dakota Dunes, Nebraska, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
West Seneca, New York, United States
Calabash, North Carolina, United States
Greensboro, North Carolina, United States
Moerhead City, North Carolina, United States
Morganton, North Carolina, United States
Cincinnati, Ohio, United States
Gallipolis, Ohio, United States
Marion, Ohio, United States
Mason, Ohio, United States
Toledo, Ohio, United States
Zanesville, Ohio, United States
Beaver, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Norristown, Pennsylvania, United States
Perryopolis, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pottstown, Pennsylvania, United States
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Johnson City, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Killeen, Texas, United States
Richardson, Texas, United States
San Antonio, Texas, United States
Schertz, Texas, United States
Sugar Land, Texas, United States
Burke, Virginia, United States
Danville, Virginia, United States
Falls Church, Virginia, United States
Hampton, Virginia, United States
Henrico, Virginia, United States
Manassas, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Selah, Washington, United States
Tacoma, Washington, United States
Salzburg, , Austria
Vienna, , Austria
Hedersem (Aalst), , Belgium
Tremelo, , Belgium
Belém, , Brazil
Brasília, , Brazil
Fortaleza, , Brazil
Goiânia, , Brazil
Marília, , Brazil
Passo Fundo, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Red Deer, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Brampton, Ontario, Canada
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Charlottetown, Prince Edward Island, Canada
Sherbrooke, Quebec, Canada
Ville, Laint-Laurent, Quebec, Canada
Pointe-Claire, , Canada
Toronto, , Canada
Aalborg, , Denmark
Ballerup Municipality, , Denmark
Gentofte Municipality, , Denmark
Vejle, , Denmark
Vipperoed, , Denmark
Bondy, , France
Dijon, , France
Marseille, , France
Nantes, , France
Narbonne, , France
Paris, , France
Pessac, , France
Saint-Etienne, , France
Berlin, , Germany
Dresden, , Germany
Eisenach, , Germany
Großheirath, , Germany
Meißen, , Germany
Bangalore, , India
Coimbatore, , India
Hyderabad, , India
Jaipur, , India
Nagpur, , India
Nashik, , India
Pune, , India
Beersheba, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Nazareth, , Israel
Rishon LeZiyyon, , Israel
Tel Aviv, , Israel
Ipoh, , Malaysia
Johor Bahru, , Malaysia
Kelantan, , Malaysia
Kuala Selangor, , Malaysia
Breda, , Netherlands
Eindhoven, , Netherlands
Groningen, , Netherlands
Leiderdorp, , Netherlands
Rotterdam, , Netherlands
Velp Gld, , Netherlands
Zoetermeer, , Netherlands
Christchurch, , New Zealand
Dunedin, , New Zealand
Rotorua, , New Zealand
Tauranga, , New Zealand
Wellington, , New Zealand
Bialystok, , Poland
Chrzanów, , Poland
Gdansk, , Poland
Kamieniec Ząbkowicki, , Poland
Krakow, , Poland
Lublin, , Poland
Sobótka, , Poland
Sopot, , Poland
Torun, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Singapore, , Singapore
Busan, , South Korea
Daegu, , South Korea
Jeonju, , South Korea
Seongnam, , South Korea
Seoul, , South Korea
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Sumy, , Ukraine
Ternopil, , 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.
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.
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.
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.
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.
Schernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, Kawaguchi M, Canovatchel W, Meininger G. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013 Sep;36(9):2508-15. doi: 10.2337/dc12-2491. Epub 2013 Apr 5.
Other Identifiers
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28431754DIA3015
Identifier Type: OTHER
Identifier Source: secondary_id
CR017185
Identifier Type: -
Identifier Source: org_study_id
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