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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:
ClinicalTrials.gov Identifier:
NCT00968812
First Posted: August 31, 2009
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
Results First Submitted: April 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
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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]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      397  82.2%      411  84.7%      399  82.8%      1207  83.2% 
>=65 years      86  17.8%      74  15.3%      83  17.2%      243  16.8% 
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]
Count of Participants
       
Female      231  47.8%      244  50.3%      219  45.4%      694  47.9% 
Male      252  52.2%      241  49.7%      263  54.6%      756  52.1% 
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
  Show All Outcome Measures

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
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Time Frame Adverse event data were collected for the duration of the study (104 weeks).
Additional Description

The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.

MEDDRA 14.1 used for Week 52 / MEDDRA 15.0 for Week 104 results.


Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Canagliflozin 100 mg: Baseline to Week 52 Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
Canagliflozin 300 mg: Baseline to Week 52 Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
Glimepiride: Baseline to Week 52 Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
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. Data are presented for Baseline to Week 104.
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. Data are presented for Baseline to Week 104.
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. Data are presented for Baseline to Week 104.

Other Adverse Events
    Canagliflozin 100 mg: Baseline to Week 52   Canagliflozin 300 mg: Baseline to Week 52   Glimepiride: Baseline to Week 52   Canagliflozin 100 mg: Baseline to Week 104   Canagliflozin 300 mg: Baseline to Week 104   Glimepiride: Baseline to Week 104
Total, Other (not including serious) Adverse Events             
# participants affected / at risk   138/483 (28.57%)   150/485 (30.93%)   175/482 (36.31%)   198/483 (40.99%)   204/485 (42.06%)   242/482 (50.21%) 
Gastrointestinal disorders             
Diarrhoea * 1             
# participants affected / at risk   24/483 (4.97%)   33/485 (6.80%)   29/482 (6.02%)   25/482 (5.19%)   39/485 (8.04%)   34/482 (7.05%) 
Nausea * 1             
# participants affected / at risk   16/483 (3.31%)   25/485 (5.15%)   13/482 (2.70%)   20/483 (4.14%)   27/485 (5.57%)   19/482 (3.94%) 
Infections and infestations             
Nasopharyngitis * 1             
# participants affected / at risk   33/483 (6.83%)   37/485 (7.63%)   37/482 (7.68%)   47/483 (9.73%)   55/485 (11.34%)   51/482 (10.58%) 
Upper respiratory tract infection * 1             
# participants affected / at risk   17/483 (3.52%)   27/485 (5.57%)   41/482 (8.51%)   36/483 (7.45%)   38/485 (7.84%)   56/482 (11.62%) 
Urinary tract infection * 1             
# participants affected / at risk   26/483 (5.38%)   23/485 (4.74%)   18/482 (3.73%)   44/483 (9.11%)   33/485 (6.80%)   27/482 (5.60%) 
Influenza * 1             
# participants affected / at risk   14/483 (2.90%)   17/485 (3.51%)   7/482 (1.45%)   25/483 (5.18%)   23/485 (4.74%)   13/482 (2.70%) 
Metabolism and nutrition disorders             
Hypoglycaemia * 1             
# participants affected / at risk   15/483 (3.11%)   9/485 (1.86%)   61/482 (12.66%)   17/483 (3.52%)   16/485 (3.30%)   86/482 (17.84%) 
Musculoskeletal and connective tissue disorders             
Back pain * 1             
# participants affected / at risk   29/483 (6.00%)   18/485 (3.71%)   20/482 (4.15%)   34/483 (7.04%)   28/485 (5.77%)   26/482 (5.39%) 
Arthralgia * 1             
# participants affected / at risk   18/483 (3.73%)   13/485 (2.68%)   18/482 (3.73%)   26/483 (5.38%)   16/485 (3.30%)   24/482 (4.98%) 
Nervous system disorders             
Headache * 1             
# participants affected / at risk   14/483 (2.90%)   25/485 (5.15%)   24/482 (4.98%)   21/483 (4.35%)   29/485 (5.98%)   33/482 (6.85%) 
Vascular disorders             
Hypertension * 1             
# participants affected / at risk   8/483 (1.66%)   10/485 (2.06%)   13/482 (2.70%)   15/483 (3.11%)   11/485 (2.27%)   30/482 (6.22%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MEDDRA 14.1 / 15.0



  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