An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01064414
First received: February 4, 2010
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: April 2, 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
Conditions: Diabetes Mellitus, Type 2
Renal Insufficiency
Interventions: Drug: Canagliflozin
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 in patients with type 2 diabetes mellitus and moderate renal impairment. The study was conducted between 02 March 2010 and 19 January 2012 and recruited patients from 89 study centers located in 19 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
272 patients were randomly allocated to the 3 treatment arms. 269 patients 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 in two parts: for Baseline to Week 26 as "Core Period", and for Week 26 to Week 52 as "Extension Period".

Reporting Groups
  Description
Placebo Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).

Participant Flow for 2 periods

Period 1:   Core Period: Baseline to Week 26
    Placebo     Canagliflozin 100 mg     Canagliflozin 300 mg  
STARTED     90     90     89  
COMPLETED     77     75     82  
NOT COMPLETED     13     15     7  
Adverse Event                 4                 4                 2  
Death                 0                 1                 0  
Protocol Violation                 1                 0                 1  
Withdrawal by Subject                 4                 2                 2  
Noncompliance with study drug                 0                 1                 0  
Not specified                 4                 7                 2  

Period 2:   Extension Period: Week 26 to Week 52
    Placebo     Canagliflozin 100 mg     Canagliflozin 300 mg  
STARTED     76 [1]   72 [2]   81 [1]
COMPLETED     64     67     76  
NOT COMPLETED     12     5     5  
Adverse Event                 2                 1                 2  
Death                 0                 1                 0  
Lost to Follow-up                 1                 0                 0  
Physician Decision                 1                 0                 0  
Withdrawal by Subject                 1                 0                 1  
Noncompliance with study drug                 1                 0                 0  
Protocol Violation                 1                 1                 1  
Not specified                 5                 2                 1  
[1] 1 pt completed core but did not enter ext. Reason: other (not specified).
[2] 3 pts completed core but did not enter ext. Reason: other (not specified) (3).



  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 once daily for 52 weeks.
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks.
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Canagliflozin 100 mg     Canagliflozin 300 mg     Total  
Number of Participants  
[units: participants]
  90     90     89     269  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     27     24     32     83  
>=65 years     63     66     57     186  
Age  
[units: years]
Mean ± Standard Deviation
  68.2  ± 8.4     69.5  ± 8.2     67.9  ± 8.24     68.5  ± 8.28  
Gender  
[units: participants]
       
Female     33     32     41     106  
Male     57     58     48     163  
Region of Enrollment  
[units: participants]
       
AUSTRALIA     3     6     5     14  
BELGIUM     5     1     6     12  
BRAZIL     4     4     5     13  
CANADA     7     11     3     21  
FRANCE     7     5     4     16  
GERMANY     6     10     2     18  
INDIA     3     3     3     9  
ITALY     4     1     1     6  
LATVIA     2     1     4     7  
MALAYSIA     2     4     8     14  
MEXICO     0     2     2     4  
NEW ZEALAND     7     2     5     14  
POLAND     5     5     4     14  
ROMANIA     2     1     2     5  
RUSSIAN FEDERATION     10     11     9     30  
SOUTH AFRICA     2     3     1     6  
SOUTH KOREA     1     1     0     2  
SPAIN     4     5     8     17  
UNITED STATES     16     14     17     47  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

2.  Secondary:   Percentage of Patients With HbA1c <7% at Week 26   [ Time Frame: Week 26 ]

3.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]


  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 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


No publications provided by Janssen Research & Development, LLC

Publications automatically indexed to this study:

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01064414     History of Changes
Other Study ID Numbers: CR017008, 28431754DIA3004
Study First Received: February 4, 2010
Results First Received: April 2, 2013
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United States: Federal Government