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An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00642278
First Posted: March 25, 2008
Last Update Posted: July 19, 2013
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):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Results First Submitted: April 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type II
Diabetes Mellitus, Non Insulin Dependent
Interventions: Drug: Canagliflozin (JNJ-28431754)
Drug: Sitagliptin
Drug: Placebo

  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) in patients with type 2 diabetes mellitus with sitagliptin as a reference arm. The study was conducted between 27 March 2008 and 28 January 2009 and recruited patients from 85 study centers located in 13 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 451 patients were randomly allocated to the 7 treatment arms in the study and comprised the intent-to-treat analysis set which was used for the efficacy analyses. All 451 patients received at least 1 dose of study drug and were included in the safety analysis set.

Reporting Groups
  Description
Placebo Each patient received matching placebo twice daily for 12 weeks.
Canagliflozin 50 mg Daily Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 100 mg Daily Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 200 mg Daily Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 300 mg Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 300 mg Twice Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
Sitagliptin 100 mg Daily Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).

Participant Flow:   Overall Study
    Placebo   Canagliflozin 50 mg Daily   Canagliflozin 100 mg Daily   Canagliflozin 200 mg Daily   Canagliflozin 300 mg Daily   Canagliflozin 300 mg Twice Daily   Sitagliptin 100 mg Daily
STARTED   65   64   64   65   64   64   65 
COMPLETED   55   59   59   56   56   57   60 
NOT COMPLETED   10   5   5   9   8   7   5 
Adverse Event                2                1                3                1                2                2                0 
Lack of Efficacy                0                1                0                0                0                0                0 
Lost to Follow-up                5                1                0                1                0                1                1 
Physician Decision                0                0                0                1                0                0                0 
Protocol Violation                0                0                1                1                0                1                2 
Withdrawal by Subject                1                1                1                3                6                2                2 
Noncompliance with study drug regimen                0                0                0                1                0                0                0 
Not specified                2                1                0                1                0                1                0 



  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
Placebo Each patient received matching placebo twice daily for 12 weeks.
Canagliflozin 50 mg Daily Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 100 mg Daily Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 200 mg Daily Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 300 mg Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 300 mg Twice Daily Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
Sitagliptin 100 mg Daily Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Total Total of all reporting groups

Baseline Measures
   Placebo   Canagliflozin 50 mg Daily   Canagliflozin 100 mg Daily   Canagliflozin 200 mg Daily   Canagliflozin 300 mg Daily   Canagliflozin 300 mg Twice Daily   Sitagliptin 100 mg Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   64   64   65   64   64   65   451 
Age 
[Units: Participants]
               
<=18 years   0   0   0   0   0   0   0   0 
Between 18 and 65 years   63   61   63   61   63   62   65   438 
>=65 years   2   3   1   4   1   2   0   13 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.3  (7.82)   53.3  (8.48)   51.7  (7.95)   52.9  (9.56)   52.3  (6.88)   55.2  (7.14)   51.7  (8.09)   52.9  (8.06) 
Gender 
[Units: Participants]
               
Female   34   30   28   32   28   36   27   215 
Male   31   34   36   33   36   28   38   236 
Region Enroll 
[Units: Participants]
               
ARGENTINA   1   1   3   1   2   0   2   10 
BULGARIA   1   1   1   0   3   3   1   10 
CANADA   11   6   9   8   8   4   7   53 
CZECH REPUBLIC   2   3   2   6   0   2   2   17 
INDIA   4   6   3   5   2   6   4   30 
MALAYSIA   3   0   6   2   4   1   3   19 
MEXICO   4   6   9   9   6   14   2   50 
POLAND   3   5   4   7   6   5   9   39 
ROMANIA   9   8   4   6   6   5   8   46 
RUSSIAN FEDERATION   5   7   5   2   6   3   4   32 
UNITED KINGDOM   1   0   2   1   3   1   2   10 
UNITED STATES   21   21   16   18   18   20   21   135 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to Week 12   [ Time Frame: Day 1 (Baseline) and Week 12 ]

2.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12   [ Time Frame: Day 1 (Baseline) and Week 12 ]

3.  Secondary:   Percentage of Patients With Symptoms of Hypoglycemia   [ Time Frame: Up to Week 12 ]

4.  Secondary:   Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12   [ Time Frame: Day 1 (Baseline) and Week 12 ]

5.  Secondary:   Absolute Change in Body Weight From Baseline to Week 12   [ Time Frame: Day 1 (Baseline) and Week 12 ]

6.  Secondary:   Percent Change in Body Weight From Baseline to Week 12   [ Time Frame: Day 1 (Baseline) and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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 text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
Organization: Janssen Research & Development, LLC
phone: 1-800-526-7736


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00642278     History of Changes
Other Study ID Numbers: CR014587
28431754DIA2001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Submitted: March 21, 2008
First Posted: March 25, 2008
Results First Submitted: April 1, 2013
Results First Posted: May 17, 2013
Last Update Posted: July 19, 2013