The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01106690
First received: April 1, 2010
Last updated: June 26, 2013
Last verified: June 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);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: Canagliflozin
Drug: Sitagliptin
Drug: Metformin
Drug: Pioglitazone

  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 with inadequate control despite treatment with metformin and pioglitazone. The study was conducted between 13 April 2010 and 20 November 2011 and recruited patients from 74 study centers in 11 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
344 patients were randomly allocated to the 3 treatment arms. 342 patients received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set (used for the Week 26 efficacy analysis) and safety analysis set (used for the Week 26 and Week 52 safety analyses).

Reporting Groups
  Description
Placebo/Sitagliptin Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.

Participant Flow for 2 periods

Period 1:   Core Period: Baseline to Week 26
    Placebo/Sitagliptin     Canagliflozin 100 mg     Canagliflozin 300 mg  
STARTED     115     113     114  
COMPLETED     91     104     101  
NOT COMPLETED     24     9     13  
Adverse Event                 6                 1                 4  
Lost to Follow-up                 1                 1                 2  
Protocol Violation                 1                 0                 0  
Withdrawal by Subject                 4                 1                 0  
Creatinine or eGFR withdrawal criteria                 0                 3                 1  
Noncompliance with study drug                 0                 1                 0  
Unable to take rescue therapy                 1                 0                 0  
Lack of efficacy on rescue therapy                 1                 0                 0  
Not specified                 10                 2                 6  

Period 2:   Extension Period: Week 26 to Week 52
    Placebo/Sitagliptin     Canagliflozin 100 mg     Canagliflozin 300 mg  
STARTED     90 [1]   103 [1]   96 [2]
COMPLETED     78     96     89  
NOT COMPLETED     12     7     7  
Adverse Event                 1                 1                 0  
Withdrawal by Subject                 1                 0                 0  
Physician Decision                 0                 2                 2  
Noncompliance with study drug                 0                 0                 1  
Unable to take rescue therapy                 1                 1                 0  
Not specified                 8                 3                 4  
Lost to Follow-up                 1                 0                 0  
[1] 1 pt completed core but did not enter ext: physician decision(1).
[2] 5 pts completed core but did not exter ext: lost to f/u(1), not spec(2), AE(1), eGFR criteria(1).



  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.
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Reporting Groups
  Description
Placebo/Sitagliptin Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Total Total of all reporting groups

Baseline Measures
    Placebo/Sitagliptin     Canagliflozin 100 mg     Canagliflozin 300 mg     Total  
Number of Participants  
[units: participants]
  115     113     114     342  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     83     83     83     249  
>=65 years     32     30     31     93  
Age  
[units: years]
Mean ± Standard Deviation
  58.3  ± 9.56     56.7  ± 10.36     57  ± 10.19     57.4  ± 10.03  
Gender  
[units: participants]
       
Female     39     36     51     126  
Male     76     77     63     216  
Region of Enrollment  
[units: participants]
       
CANADA     24     22     21     67  
FINLAND     7     3     3     13  
FRANCE     1     0     1     2  
GERMANY     7     5     7     19  
GREECE     0     0     1     1  
INDIA     10     10     5     25  
MEXICO     7     3     11     21  
SPAIN     8     5     2     15  
THAILAND     5     8     4     17  
UNITED KINGDOM     3     2     3     8  
UNITED STATES     43     55     56     154  



  Outcome Measures
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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 ]

4.  Secondary:   Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

5.  Secondary:   Percent Change in Body Weight From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

6.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

7.  Secondary:   Percent Change in Triglycerides From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

8.  Secondary:   Percent Change in High-density Lipoprotein Cholesterol (HDL-C) 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
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  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: NCT01106690     History of Changes
Other Study ID Numbers: CR017032, 28431754DIA3012
Study First Received: April 1, 2010
Results First Received: April 2, 2013
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration
Great Britain: Medicines and Healthcare Products Regulatory Agency