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

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ClinicalTrials.gov Identifier: NCT00968812
Recruitment Status : Completed
First Posted : August 31, 2009
Results First Posted : June 4, 2013
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2013

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and 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.


Secondary Outcome Measures :
  1. Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ]
    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.

  2. Percent Change in Body Weight From Baseline to Week 52 [ Time Frame: Day 1 (Baseline) and Week 52 ]
    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.

  3. Change in HbA1c From Baseline to Week 104 [ Time Frame: Baseline, Week 104 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00968812


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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00968812     History of Changes
Other Study ID Numbers: CR016480
28431754DIA3009 ( Other Identifier: Janssen Research & Development, LLC )
2009-009320-36 ( EudraCT Number )
First Posted: August 31, 2009    Key Record Dates
Results First Posted: June 4, 2013
Last Update Posted: January 30, 2017
Last Verified: December 2016
Keywords provided by Janssen Research & Development, LLC:
Diabetes
Metformin
Glimepiride
 Hemoglobin A1c
Type 2 diabetes mellitus
Canagliflozin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Glimepiride
Canagliflozin
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action