CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

NCT00968812 | Completed Phase 3 Results DMC

• 3 other identifiers: CR01648028431754DIA30092009-009320-36
• Study Type: interventional
• Target: 1,452
• Locations: 20 countries
• Sites: 138

Brief Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Metformin; Glimepiride; Hemoglobin A1c; Type 2 diabetes mellitus; Canagliflozin

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 52

  The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

  Day 1 (Baseline) and Week 52

Secondary Outcomes (3)

• Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52

  Day 1 (Baseline) and Week 52

• Percent Change in Body Weight From Baseline to Week 52

  Day 1 (Baseline) and Week 52

• Change in HbA1c From Baseline to Week 104

  Baseline, Week 104

Study Arms (3)

Glimepiride

ACTIVE COMPARATOR

Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.

Drug: Glimepiride; Drug: Metformin

Canagliflozin 100 mg

EXPERIMENTAL

Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.

Drug: Canagliflozin (JNJ-28431754); Drug: Metformin

Canagliflozin 300 mg

EXPERIMENTAL

Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.

Drug: Canagliflozin (JNJ-28431754); Drug: Metformin

Interventions

Glimepiride DRUG

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.

Also known as: sulfonylurea

Glimepiride

Canagliflozin (JNJ-28431754) DRUG

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.

Canagliflozin 100 mg; Canagliflozin 300 mg

Metformin DRUG

Metformin will be given orally at the protocol-specified dose for 104 weeks.

Canagliflozin 100 mg; Canagliflozin 300 mg; Glimepiride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of type 2 diabetes
• 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

You may not qualify if:

• Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (138)

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Calera, Alabama, United States

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Gilbert, Arizona, United States

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Mesa, Arizona, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Buena Park, California, United States

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Encinitas, California, United States

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Fresno, California, United States

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Lincoln, California, United States

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Roseville, California, United States

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San Diego, California, United States

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Westlake Village, California, United States

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Chipley, Florida, United States

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Marianna, Florida, United States

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Oldsmar, Florida, United States

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Orlando, Florida, United States

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Augusta, Georgia, United States

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Perry, Georgia, United States

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Nampa, Idaho, United States

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Chicago, Illinois, United States

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Vernon Hills, Illinois, United States

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Valparaiso, Indiana, United States

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New Orleans, Louisiana, United States

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Elkridge, Maryland, United States

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Bloomfield Hills, Michigan, United States

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Las Vegas, Nevada, United States

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Canal Fulton, Ohio, United States

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Gallipolis, Ohio, United States

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Mason, Ohio, United States

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Perrysburg, Ohio, United States

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Tulsa, Oklahoma, United States

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Yukon, Oklahoma, United States

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Fleetwood, Pennsylvania, United States

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Greenville, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Odessa, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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Danville, Virginia, United States

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Olympia, Washington, United States

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Milwaukee, Wisconsin, United States

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Wauwatosa, Wisconsin, United States

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Buenos Aires, Argentina

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Mar del Plata, Argentina

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Rosario, Argentina

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Dimitrovgrad, Bulgaria

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Kazanlak, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Chilliwack, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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San José, Costa Rica

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San Pedro, Costa Rica

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Aalborg, Denmark

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Ballerup Municipality, Denmark

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Vejle, Denmark

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Vipperoed, Denmark

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Helsinki, Finland

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Kokkola, Finland

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Kuopio, Finland

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Oulu, Finland

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Turku, Finland

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Berlin, Germany

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Dresden, Germany

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Düsseldorf, Germany

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Hamburg, Germany

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Mainz, Germany

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Villingen-Schwenningen, Germany

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Bangalore, India

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Chennai, India

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Coimbatore, India

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Hyderabad, India

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Nagpur, India

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Pune, India

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Wardha, India

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Beersheba, Israel

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Haifa, Israel

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Holon, Israel

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Jerusalem, Israel

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Ramat Gan, Israel

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Rehovot, Israel

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Safed, Israel

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Tel Aviv, Israel

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Mexico City, Mexico

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México, Mexico

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Monterrey, Mexico

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Ålesund, Norway

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Oslo, Norway

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Cebu, Philippines

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Marikina City, Philippines

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Pasay, Philippines

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Quezon City, Philippines

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Bydgoszcz, Poland

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Krakow, Poland

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Kutno, Poland

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Lodz, Poland

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Lublin, Poland

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Torun, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Zielona Góra, Poland

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Ponce, Puerto Rico

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Baia Mare, Romania

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Brasov, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Galati, Romania

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Ploieşti, Romania

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Târgu Mureş, Romania

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Arkhangelsk, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Saratov, Russia

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Ľubochňa, Slovakia

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Prešov, Slovakia

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Daegu, South Korea

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Goyang-si, South Korea

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Gyeonggi-do, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Wŏnju, South Korea

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Dnipro, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Poltava, Ukraine

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Ternopil, Ukraine

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Vinnitsa, Ukraine

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Related Publications (13)

• 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.

  PMID: 38770818 DERIVED

• 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.

  PMID: 31001673 DERIVED

• 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.

  PMID: 29452178 DERIVED

• 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.

  PMID: 27977934 DERIVED

• 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.

  PMID: 27600862 DERIVED

• 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.

  PMID: 27495291 DERIVED

• 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.

  PMID: 27002421 DERIVED

• 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.

  PMID: 26984361 DERIVED

• 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.

  PMID: 26580237 DERIVED

• 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.

  PMID: 26579834 DERIVED

• 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.

  PMID: 25205142 DERIVED

• 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.

  PMID: 24517339 DERIVED

• 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.

  PMID: 23850055 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

glimepiride; Sulfonylurea Compounds; Canagliflozin; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Thiophenes; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines

Limitations and Caveats

No notable study limitations were identified by the Sponsor.

Results Point of Contact

• Title: Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
• Organization: Janssen Research & Development, LLC

1-800-526-7736

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2013
• Last Updated: January 30, 2017
• Results First Posted: June 4, 2013

Record last verified: 2016-12

Locations

AR (3); US (43); CA (8); IL (8); NO (2); IN (7); PL (9); PR (1); FI (5); DE (6); CO (2); KR (7); UA (6); ME (3); PH (4); RO (7); SL (4); RU (5); BU (4); DK (4)