CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Glimepiride Drug: Canagliflozin (JNJ-28431754) Drug: Metformin |
Phase | Phase 3 |
Sponsor | Janssen Research & Development, LLC |
Responsible Party | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier | NCT00968812 |
First Received | August 28, 2009 |
Last Updated | April 3, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | August 28, 2009 |
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Last Updated Date | April 3, 2014 |
Start Date | September 2009 |
Estimated Primary Completion Date | January 2013 |
Current Primary Outcome Measures | Change in HbA1c From Baseline to Week 52 [Time Frame: Day 1 (Baseline) and Week 52] [Designated as safety issue: No]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. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride |
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Official Title | A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy |
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. |
Detailed Description | Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea (glimepiride) in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of canagliflozin (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: 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. Other Names: sulfonylureaDrug: 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. Drug: Metformin Metformin will be given orally at the protocol-specified dose for 104 weeks. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 1452 |
Estimated Completion Date | January 2013 |
Estimated Primary Completion Date | December 2011 |
Eligibility Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Argentina, Bulgaria, Canada, Costa Rica, Denmark, Finland, Germany, India, Israel, Korea, Republic of, Mexico, Norway, Philippines, Poland, Romania, Russian Federation, Slovakia, Ukraine |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00968812 |
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Other Study ID Numbers | CR016480 |
Has Data Monitoring Committee | Yes |
Information Provided By | Janssen Research & Development, LLC |
Study Sponsor | Janssen Research & Development, LLC |
Collaborators | Not Provided |
Investigators | Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
United States, Alabama | Calera, Alabama, United States |
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United States, Arizona | Gilbert, Arizona, United States |
United States, Arizona | Mesa, Arizona, United States |
United States, Arizona | Tucson, Arizona, United States |
United States, Arkansas | Jonesboro, Arkansas, United States |
United States, California | Buena Park, California, United States |
United States, California | Encinitas, California, United States |
United States, California | Fresno, California, United States |
United States, California | Lincoln, California, United States |
United States, California | Roseville, California, United States |
United States, California | San Diego, California, United States |
United States, California | Westlake Village, California, United States |
United States, Florida | Chipley, Florida, United States |
United States, Florida | Marianna, Florida, United States |
United States, Florida | Oldsmar, Florida, United States |
United States, Florida | Orlando, Florida, United States |
United States, Georgia | Augusta, Georgia, United States |
United States, Georgia | Perry, Georgia, United States |
United States, Idaho | Nampa, Idaho, United States |
United States, Illinois | Chicago, Illinois, United States |
United States, Illinois | Vernon Hills, Illinois, United States |
United States, Indiana | Valparaiso, Indiana, United States |
United States, Louisiana | New Orleans, Louisiana, United States |
United States, Maryland | Elkridge, Maryland, United States |
United States, Maryland | Hyattsville, Maryland, United States |
United States, Michigan | Bloomfield Hills, Michigan, United States |
United States, Nevada | Las Vegas, Nevada, United States |
United States, Ohio | Canal Fulton, Ohio, United States |
United States, Ohio | Mason, Ohio, United States |
United States, Ohio | Perrysburg, Ohio, United States |
United States, Oklahoma | Tulsa, Oklahoma, United States |
United States, Oklahoma | Yukon, Oklahoma, United States |
United States, Pennsylvania | Fleetwood, Pennsylvania, United States |
United States, South Carolina | Greenville, South Carolina, United States |
United States, Tennessee | Nashville, Tennessee, United States |
United States, Texas | Houston, Texas, United States |
United States, Texas | Odessa, Texas, United States |
United States, Texas | Pearland, Texas, United States |
United States, Texas | San Antonio, Texas, United States |
United States, Virginia | Danville, Virginia, United States |
United States, Washington | Olympia, Washington, United States |
United States, Wisconsin | Milwaukee, Wisconsin, United States |
United States, Wisconsin | Wauwatosa, Wisconsin, United States |
Argentina | Buenos Aires, Argentina |
Argentina | Mar Del Plata, Argentina |
Argentina | Rosario, Argentina |
Bulgaria | Dimitrovgrad, Bulgaria |
Bulgaria | Kazanlak, Bulgaria |
Bulgaria | Rousse, Bulgaria |
Bulgaria | Sofia, Bulgaria |
Canada, British Columbia | Chilliwack, British Columbia, Canada |
Canada, British Columbia | Kelowna, British Columbia, Canada |
Canada, British Columbia | Vancouver, British Columbia, Canada |
Canada, Newfoundland and Labrador | St. John'S, Newfoundland and Labrador, Canada |
Canada, Ontario | Mississauga, Ontario, Canada |
Canada, Ontario | Toronto, Ontario, Canada |
Canada, Saskatchewan | Saskatoon, Saskatchewan, Canada |
Canada | Quebec, Canada |
Costa Rica | San Jose, Costa Rica |
Costa Rica | San Pedro, Costa Rica |
Denmark | Aalborg, Denmark |
Denmark | Ballerup, Denmark |
Denmark | Vejle, Denmark |
Denmark | Vipperoed, Denmark |
Finland | Helsinki, Finland |
Finland | Kokkola, Finland |
Finland | Kuopio, Finland |
Finland | Oulu, Finland |
Finland | Turku, Finland |
Germany | Berlin, Germany |
Germany | Dresden, Germany |
Germany | Duesseldorf, Germany |
Germany | Hamburg, Germany |
Germany | Mainz, Germany |
Germany | Villingen-Schwenningen, Germany |
India | Bangalore, India |
India | Chennai, India |
India | Coimbatore, India |
India | Hyderabad, India |
India | Nagpur, India |
India | Pune, India |
India | Wardha, India |
Israel | Beer Sheba, Israel |
Israel | Haifa, Israel |
Israel | Holon, Israel |
Israel | Jerusalem, Israel |
Israel | Ramat Gan, Israel |
Israel | Rehovot, Israel |
Israel | Tel Aviv, Israel |
Israel | Tel-Aviv, Israel |
Israel | Zefat, Israel |
Korea, Republic of | Daegu, Korea, Republic of |
Korea, Republic of | Goyang-Si, Korea, Republic of |
Korea, Republic of | Gyeonggi-Do, Korea, Republic of |
Korea, Republic of | Incheon, Korea, Republic of |
Korea, Republic of | Seoul, Korea, Republic of |
Korea, Republic of | Suwon, Korea, Republic of |
Korea, Republic of | Wonju-Si, Korea, Republic of |
Mexico | Ciudad De Mexico, Mexico |
Mexico | Mexico, Mexico |
Mexico | Monterrey, Mexico |
Norway | Alesund, Norway |
Norway | Oslo, Norway |
Philippines | Cebu, Philippines |
Philippines | Marikina City, Philippines |
Philippines | Pasay, Philippines |
Philippines | Quezon City, Philippines |
Poland | Bydgoszcz, Poland |
Poland | Krakow, Poland |
Poland | Kutno 001, Poland |
Poland | Lodz, Poland |
Poland | Lublin, Poland |
Poland | Torun, Poland |
Poland | Warszawa, Poland |
Poland | Wroclaw, Poland |
Poland | Zielona Gora, Poland |
Puerto Rico | Ponce, Puerto Rico |
Romania | Baia Mare, Romania |
Romania | Brasov, Romania |
Romania | Bucharest, Romania |
Romania | Cluj, Romania |
Romania | Galati, Romania |
Romania | Ploiesti, Romania |
Romania | Targu Mures, Romania |
Russian Federation | Arkhangelsk, Russian Federation |
Russian Federation | Moscow, Russian Federation |
Russian Federation | Saint Petersburg, Russian Federation |
Russian Federation | Samara, Russian Federation |
Russian Federation | Saratov, Russian Federation |
Russian Federation | St Petersburg, Russian Federation |
Slovakia | Banska Bystrica, Slovakia |
Slovakia | Bratislava, Slovakia |
Slovakia | Lubochna, Slovakia |
Slovakia | Presov, Slovakia |
Ukraine | Dnepropetrovsk, Ukraine |
Ukraine | Kharkov, Ukraine |
Ukraine | Kiev, Ukraine |
Ukraine | Kiew, Ukraine |
Ukraine | Poltava, Ukraine |
Ukraine | Ternopil, Ukraine |
Ukraine | Vinnitsa, Ukraine |