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


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Baseline Measures
    Canagliflozin 100 mg     Canagliflozin 300 mg     Glimepiride     Total  
Number of Participants  
[units: participants]
  483     485     482     1450  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     397     411     399     1207  
>=65 years     86     74     83     243  
Age  
[units: years]
Mean ± Standard Deviation
  56.4  ± 9.49     55.8  ± 9.17     56.3  ± 9.01     56.2  ± 9.22  
Gender  
[units: participants]
       
Female     231     244     219     694  
Male     252     241     263     756  
Region Enroll  
[units: participants]
       
ARGENTINA     18     18     18     54  
BULGARIA     7     7     7     21  
CANADA     19     20     19     58  
COSTA RICA     10     9     9     28  
DENMARK     24     25     25     74  
FINLAND     18     17     19     54  
GERMANY     6     7     6     19  
INDIA     55     55     56     166  
ISRAEL     14     15     14     43  
MEXICO     24     25     24     73  
NORWAY     9     9     9     27  
PHILIPPINES     14     13     13     40  
POLAND     14     15     15     44  
ROMANIA     43     43     44     130  
RUSSIAN FEDERATION     23     22     22     67  
SLOVAKIA     15     14     13     42  
SOUTH KOREA     31     32     31     94  
UKRAINE     22     22     22     66  
UNITED STATES     117     117     116     350  



  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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