CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
NCT ID: NCT00968812
Last Updated: 2017-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1452 participants
INTERVENTIONAL
2009-09-30
2013-01-31
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
QUADRUPLE
Study Groups
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Glimepiride
Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
Glimepiride
Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.
Metformin
Metformin will be given orally at the protocol-specified dose for 104 weeks.
Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Canagliflozin (JNJ-28431754)
Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.
Metformin
Metformin will be given orally at the protocol-specified dose for 104 weeks.
Canagliflozin 300 mg
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Canagliflozin (JNJ-28431754)
Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.
Metformin
Metformin will be given orally at the protocol-specified dose for 104 weeks.
Interventions
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Glimepiride
Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.
Canagliflozin (JNJ-28431754)
Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.
Metformin
Metformin will be given orally at the protocol-specified dose for 104 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) \>=22 to \<=45 kg/m2, at screening
* Patients must be taking a stable dosage of metformin as monotherapy at screening
* Patients must have a HbA1c between \>=7% and \<=9.5% at Week 2
* Patients must have a fasting plasma glucose (FPG) \<=270 mg/dL (15 mmol/L) at Week -2
Exclusion Criteria
* History of diabetic ketoacidosis or type 1 diabetes mellitus
* History of pancreas or beta-cell transplantation
* History of active proliferative diabetic retinopathy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
* Taken thiazolidinedione therapy in the past 16 weeks before screening
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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Calera, Alabama, United States
Gilbert, Arizona, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Buena Park, California, United States
Encinitas, California, United States
Fresno, California, United States
Lincoln, California, United States
Roseville, California, United States
San Diego, California, United States
Westlake Village, California, United States
Chipley, Florida, United States
Marianna, Florida, United States
Oldsmar, Florida, United States
Orlando, Florida, United States
Augusta, Georgia, United States
Perry, Georgia, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Vernon Hills, Illinois, United States
Valparaiso, Indiana, United States
New Orleans, Louisiana, United States
Elkridge, Maryland, United States
Bloomfield Hills, Michigan, United States
Las Vegas, Nevada, United States
Canal Fulton, Ohio, United States
Gallipolis, Ohio, United States
Mason, Ohio, United States
Perrysburg, Ohio, United States
Tulsa, Oklahoma, United States
Yukon, Oklahoma, United States
Fleetwood, Pennsylvania, United States
Greenville, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Odessa, Texas, United States
Pearland, Texas, United States
San Antonio, Texas, United States
Danville, Virginia, United States
Olympia, Washington, United States
Milwaukee, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Buenos Aires, , Argentina
Mar del Plata, , Argentina
Rosario, , Argentina
Dimitrovgrad, , Bulgaria
Kazanlak, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Chilliwack, British Columbia, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
San José, , Costa Rica
San Pedro, , Costa Rica
Aalborg, , Denmark
Ballerup Municipality, , Denmark
Vejle, , Denmark
Vipperoed, , Denmark
Helsinki, , Finland
Kokkola, , Finland
Kuopio, , Finland
Oulu, , Finland
Turku, , Finland
Berlin, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Hamburg, , Germany
Mainz, , Germany
Villingen-Schwenningen, , Germany
Bangalore, , India
Chennai, , India
Coimbatore, , India
Hyderabad, , India
Nagpur, , India
Pune, , India
Wardha, , India
Beersheba, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Safed, , Israel
Tel Aviv, , Israel
Mexico City, , Mexico
México, , Mexico
Monterrey, , Mexico
Ålesund, , Norway
Oslo, , Norway
Cebu, , Philippines
Marikina City, , Philippines
Pasay, , Philippines
Quezon City, , Philippines
Bydgoszcz, , Poland
Krakow, , Poland
Kutno, , Poland
Lodz, , Poland
Lublin, , Poland
Torun, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Zielona Góra, , Poland
Ponce, , Puerto Rico
Baia Mare, , Romania
Brasov, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Galati, , Romania
Ploieşti, , Romania
Târgu Mureş, , Romania
Arkhangelsk, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Ľubochňa, , Slovakia
Prešov, , Slovakia
Daegu, , South Korea
Goyang-si, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Wŏnju, , South Korea
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Poltava, , Ukraine
Ternopil, , Ukraine
Vinnitsa, , Ukraine
Countries
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References
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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.
Heerspink HJL, Perco P, Mulder S, Leierer J, Hansen MK, Heinzel A, Mayer G. Canagliflozin reduces inflammation and fibrosis biomarkers: a potential mechanism of action for beneficial effects of SGLT2 inhibitors in diabetic kidney disease. Diabetologia. 2019 Jul;62(7):1154-1166. doi: 10.1007/s00125-019-4859-4. Epub 2019 Apr 17.
Garvey WT, Van Gaal L, Leiter LA, Vijapurkar U, List J, Cuddihy R, Ren J, Davies MJ. Effects of canagliflozin versus glimepiride on adipokines and inflammatory biomarkers in type 2 diabetes. Metabolism. 2018 Aug;85:32-37. doi: 10.1016/j.metabol.2018.02.002. Epub 2018 Feb 13.
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.
Patel CA, Bailey RA, Vijapurkar U, Meininger G, Blonde L. A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures. BMC Health Serv Res. 2016 Aug 5;16(a):356. doi: 10.1186/s12913-016-1607-z.
Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.
Leiter LA, Langslet G, Vijapurkar U, Davies MJ, Canovatchel W. Simultaneous Reduction in Both HbA1c and Body Weight with Canagliflozin Versus Glimepiride in Patients with Type 2 Diabetes on Metformin. Diabetes Ther. 2016 Jun;7(2):269-78. doi: 10.1007/s13300-016-0163-1. Epub 2016 Mar 16.
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.
Leiter LA, Yoon KH, Arias P, Langslet G, Xie J, Balis DA, Millington D, Vercruysse F, Canovatchel W, Meininger G. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015 Mar;38(3):355-64. doi: 10.2337/dc13-2762. Epub 2014 Sep 9.
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.
Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50. doi: 10.1016/S0140-6736(13)60683-2. Epub 2013 Jul 12.
Other Identifiers
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28431754DIA3009
Identifier Type: OTHER
Identifier Source: secondary_id
2009-009320-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR016480
Identifier Type: -
Identifier Source: org_study_id
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