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
Results First Received: April 17, 2013  
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
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Glimepiride
Drug: Canagliflozin (JNJ-28431754)
Drug: Metformin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) compared with glimepiride in participants with type 2 diabetes mellitus with inadequate glycemic control despite metformin treatment. The study was conducted between 28 August 2009 and 25 January 2013 and included 157 study centers in 19 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1,452 participants were randomly allocated to the 3 treatment arms. 1450 participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set and safety analysis set. Participant flow is presented for Baseline to Week 104.

Reporting Groups
  Description
Canagliflozin 100 mg: Baseline to Week 104 Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Canagliflozin 300 mg: Baseline to Week 104 Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Glimepiride: Baseline to Week 104 Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.

Participant Flow:   Overall Study
    Canagliflozin 100 mg: Baseline to Week 104     Canagliflozin 300 mg: Baseline to Week 104     Glimepiride: Baseline to Week 104  
STARTED     483     485     482  
COMPLETED     343     323     314  
NOT COMPLETED     140     162     168  
Adverse Event                 30                 46                 33  
Death                 2                 2                 1  
Lack of Efficacy                 9                 7                 16  
Lost to Follow-up                 17                 12                 11  
Physician Decision                 8                 5                 9  
Protocol Violation                 7                 4                 3  
Withdrawal by Subject                 17                 23                 25  
Creatinine or eGFR withdrawal criteria                 9                 13                 7  
Noncompliance with study drug                 4                 1                 6  
Unable to take rescue therapy                 12                 12                 17  
Not specified                 25                 37                 40  



  Baseline Characteristics


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

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

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

4.  Secondary:   Change in HbA1c From Baseline to Week 104   [ Time Frame: Baseline, Week 104 ]
Results not yet posted.   Anticipated Posting Date:   01/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No notable study limitations were identified by the Sponsor.


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