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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00968812
First received: August 28, 2009
Last updated: April 3, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Glimepiride
Drug: Canagliflozin (JNJ-28431754)
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

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.


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.


Enrollment: 1452
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 Name: sulfonylurea
Drug: Metformin
Metformin will be given orally at the protocol-specified dose 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.
Drug: 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.
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.
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968812

  Hide Study Locations
Locations
United States, Alabama
Calera, Alabama, United States
United States, Arizona
Gilbert, Arizona, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Jonesboro, Arkansas, United States
United States, California
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
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Chipley, Florida, United States
Marianna, Florida, United States
Oldsmar, Florida, United States
Orlando, Florida, United States
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Augusta, Georgia, United States
Perry, Georgia, United States
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Nampa, Idaho, United States
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Chicago, Illinois, United States
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
Hyattsville, 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
Mason, Ohio, United States
Perrysburg, Ohio, United States
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Tulsa, Oklahoma, United States
Yukon, Oklahoma, United States
United States, Pennsylvania
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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Olympia, Washington, United States
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Milwaukee, Wisconsin, United States
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Mar Del Plata, Argentina
Rosario, Argentina
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Rousse, Bulgaria
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St. John'S, Newfoundland and Labrador, Canada
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Toronto, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
Canada
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Denmark
Aalborg, Denmark
Ballerup, Denmark
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Vipperoed, Denmark
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Turku, Finland
Germany
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Mainz, Germany
Villingen-Schwenningen, Germany
India
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Nagpur, India
Pune, India
Wardha, India
Israel
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Haifa, Israel
Holon, Israel
Jerusalem, Israel
Ramat Gan, Israel
Rehovot, Israel
Tel Aviv, Israel
Tel-Aviv, Israel
Zefat, Israel
Korea, Republic of
Daegu, Korea, Republic of
Goyang-Si, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Wonju-Si, Korea, Republic of
Mexico
Ciudad De Mexico, Mexico
Mexico, Mexico
Monterrey, Mexico
Norway
Alesund, Norway
Oslo, Norway
Philippines
Cebu, Philippines
Marikina City, Philippines
Pasay, Philippines
Quezon City, Philippines
Poland
Bydgoszcz, Poland
Krakow, Poland
Kutno 001, Poland
Lodz, Poland
Lublin, Poland
Torun, Poland
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Wroclaw, Poland
Zielona Gora, Poland
Puerto Rico
Ponce, Puerto Rico
Romania
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Galati, Romania
Ploiesti, Romania
Targu Mures, Romania
Russian Federation
Arkhangelsk, Russian Federation
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Saratov, Russian Federation
St Petersburg, Russian Federation
Slovakia
Banska Bystrica, Slovakia
Bratislava, Slovakia
Lubochna, Slovakia
Presov, Slovakia
Ukraine
Dnepropetrovsk, Ukraine
Kharkov, Ukraine
Kiev, Ukraine
Kiew, Ukraine
Poltava, Ukraine
Ternopil, Ukraine
Vinnitsa, Ukraine
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided by Janssen Research & Development, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00968812     History of Changes
Other Study ID Numbers: CR016480, 28431754DIA3009
Study First Received: August 28, 2009
Results First Received: April 17, 2013
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
Philippines: Bureau of Food and Drugs

Keywords provided by Janssen Research & Development, LLC:
Diabetes
Metformin
Glimepiride
Hemoglobin A1c
Type 2 diabetes mellitus
Canagliflozin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014