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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: September 19, 2016
Last verified: September 2016
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 
Overall Participants Analyzed 
[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 ]


  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.


  More Information