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.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Glimepiride
Drug: Canagliflozin (JNJ-28431754)
Drug: Metformin
PhasePhase 3
SponsorJanssen Research & Development, LLC
Responsible PartyJanssen Research & Development, LLC
ClinicalTrials.gov IdentifierNCT00968812
First ReceivedAugust 28, 2009
Last UpdatedApril 3, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateAugust 28, 2009
Last Updated DateApril 3, 2014
Start DateSeptember 2009
Estimated Primary Completion DateJanuary 2013
Current Primary Outcome MeasuresChange 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
  • Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 [Time Frame: Day 1 (Baseline) and Week 52] [Designated as safety issue: Yes]The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.
  • Percent Change in Body Weight 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 percent change in body weight 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 percent change.
  • Change in HbA1c From Baseline to Week 104 [Time Frame: Baseline, Week 104] [Designated as safety issue: No]The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

Descriptive Information[ + expand ][ + ]

Brief TitleCANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Official TitleA 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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: 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)
  • Active Comparator: Glimepiride
    Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
  • Experimental: Canagliflozin 100 mg
    Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
  • Experimental: Canagliflozin 300 mg
    Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment1452
Estimated Completion DateJanuary 2013
Estimated Primary Completion DateDecember 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited 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
Other Study ID NumbersCR016480
Has Data Monitoring CommitteeYes
Information Provided ByJanssen Research & Development, LLC
Study SponsorJanssen Research & Development, LLC
CollaboratorsNot Provided
Investigators Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Verification DateApril 2014

Locations[ + expand ][ + ]

United States, Alabama
Calera, Alabama, United States
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