An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00642278 |
Recruitment Status :
Completed
First Posted : March 25, 2008
Results First Posted : May 17, 2013
Last Update Posted : July 19, 2013
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Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Study Type | Interventional |
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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 |
Enrollment | 451 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | 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 |
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Each patient received matching placebo twice daily for 12 weeks. | 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). | 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). | 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). | 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). | Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks. | Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). |
Period Title: Overall Study | |||||||
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 |
Reason Not Completed | |||||||
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 |
Other | 2 | 1 | 0 | 1 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | 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 | |
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Each patient received matching placebo twice daily for 12 weeks. | 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). | 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). | 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). | 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). | Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks. | Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening). | Total of all reporting groups | |
Overall Number of Baseline Participants | 65 | 64 | 64 | 65 | 64 | 64 | 65 | 451 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 64 participants | 64 participants | 65 participants | 64 participants | 64 participants | 65 participants | 451 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
63 96.9%
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61 95.3%
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63 98.4%
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61 93.8%
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63 98.4%
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62 96.9%
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65 100.0%
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438 97.1%
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>=65 years |
2 3.1%
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3 4.7%
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1 1.6%
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4 6.2%
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1 1.6%
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2 3.1%
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0 0.0%
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13 2.9%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 65 participants | 64 participants | 64 participants | 65 participants | 64 participants | 64 participants | 65 participants | 451 participants | |
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) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 64 participants | 64 participants | 65 participants | 64 participants | 64 participants | 65 participants | 451 participants | |
Female |
34 52.3%
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30 46.9%
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28 43.8%
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32 49.2%
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28 43.8%
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36 56.3%
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27 41.5%
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215 47.7%
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Male |
31 47.7%
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34 53.1%
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36 56.3%
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33 50.8%
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36 56.3%
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28 43.8%
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38 58.5%
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236 52.3%
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Region Enroll
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 65 participants | 64 participants | 64 participants | 65 participants | 64 participants | 64 participants | 65 participants | 451 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
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
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 |
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 |