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The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01106677
First received: April 1, 2010
Last updated: July 25, 2013
Last verified: July 2013
Results First Received: April 4, 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 immediate release

  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 compared with sitagliptin and placebo in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin. The study was conducted between 07 April 2010 and 17 August 2012 and recruited patients from 169 study centers in 22 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1,284 patients were randomly allocated to the 4 treatment arms. All 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 and week 52 efficacy analyses). All 1,284 patients were included in the Week 26 and Week 52 safety analysis sets.

Reporting Groups
  Description
Placebo/Sitagliptin Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Sitagliptin 100 mg Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.

Participant Flow for 2 periods

Period 1:   Core Period: Baseline to Week 26
    Placebo/Sitagliptin   Canagliflozin 100 mg   Canagliflozin 300 mg   Sitagliptin 100 mg
STARTED   183   368   367   366 
COMPLETED   155   322   323   319 
NOT COMPLETED   28   46   44   47 
Adverse Event                7                18                6                8 
Death                0                0                1                0 
Lack of Efficacy                1                0                0                0 
Lost to Follow-up                3                1                6                3 
Physician Decision                2                1                3                1 
Protocol Violation                0                1                0                3 
Withdrawal by Subject                5                3                15                6 
Creatinine or eGFR withdrawal criteria                1                2                2                3 
Noncompliance with study drug                1                3                0                0 
Study terminated by sponsor                0                1                2                0 
Product quality complaint                0                1                1                0 
Not specified                8                14                8                23 
Pregnancy                0                1                0                0 

Period 2:   Extension Period: Week 26 to Week 52
    Placebo/Sitagliptin   Canagliflozin 100 mg   Canagliflozin 300 mg   Sitagliptin 100 mg
STARTED   153 [1]   316 [2]   321 [3]   313 [4] 
COMPLETED   138   298   299   285 
NOT COMPLETED   15   18   22   28 
Adverse Event                1                1                5                9 
Death                0                0                0                1 
Lack of Efficacy                2                0                0                4 
Lost to Follow-up                0                2                2                2 
Physician Decision                2                3                2                3 
Protocol Violation                1                0                0                0 
Withdrawal by Subject                1                3                2                1 
Creatinine or eGFR withdrawal criteria                2                4                3                2 
Unable to take rescue therapy                0                0                0                1 
Not specified                6                5                8                5 
[1] 2 pts completed core but did not enter ext: protcol violation(1), lost to f/u(1).
[2] 6 pts completed core but did not enter ext: not specified(5), withdrawal by subject(1).
[3] 2 pts completed core but did not enter ext: not specified(1), withdrawal by subject(1).
[4] 6 pts completed core but did not enter ext: not specified(3), physician decision(2), lost to f/u(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.
No text entered.

Reporting Groups
  Description
Placebo/Sitagliptin Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
Canagliflozin 100 mg Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Canagliflozin 300 mg Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Sitagliptin 100 mg Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Total Total of all reporting groups

Baseline Measures
   Placebo/Sitagliptin   Canagliflozin 100 mg   Canagliflozin 300 mg   Sitagliptin 100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 183   368   367   366   1284 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   146   314   309   309   1078 
>=65 years   37   54   58   57   206 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (9.76)   55.5  (9.38)   55.3  (9.19)   55.5  (9.55)   55.4  (9.42) 
Gender 
[Units: Participants]
         
Female   89   194   202   194   679 
Male   94   174   165   172   605 
Region Enroll 
[Units: Participants]
         
ARGENTINA   8   9   15   11   43 
BULGARIA   4   2   1   3   10 
COLOMBIA   4   15   8   15   42 
CZECH REPUBLIC   7   8   8   7   30 
ESTONIA   6   6   3   5   20 
GREECE   1   1   3   4   9 
INDIA   13   28   31   22   94 
ITALY   2   3   3   1   9 
LATVIA   3   7   6   10   26 
MALAYSIA   9   7   11   7   34 
MEXICO   12   20   26   18   76 
PERU   16   36   30   37   119 
POLAND   1   18   14   10   43 
PORTUGAL   1   1   0   2   4 
RUSSIAN FEDERATION   15   34   28   22   99 
SINGAPORE   3   5   3   3   14 
SLOVAKIA   12   16   21   17   66 
SWEDEN   3   3   2   4   12 
THAILAND   4   9   11   8   32 
TURKEY   1   5   11   9   26 
UKRAINE   8   24   29   30   91 
UNITED STATES   50   111   103   121   385 


  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 ]

4.  Secondary:   Change in 2-hour Post-prandial Glucose 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 ]

9.  Secondary:   Change in HbA1c From Baseline to Week 52   [ Time Frame: Day 1 (Baseline) and Week 52 ]

10.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52   [ Time Frame: Day 1 (Baseline) and Week 52 ]

11.  Secondary:   Percent Change in Body Weight From Baseline to Week 52   [ Time Frame: Day 1 (Baseline) and Week 52 ]

12.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 52   [ Time Frame: Day 1 (Baseline) and Week 52 ]

13.  Secondary:   Percent Change in Triglycerides From Baseline to Week 52   [ Time Frame: Day 1 (Baseline) and Week 52 ]

14.  Secondary:   Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52   [ Time Frame: Day 1 (Baseline) and Week 52 ]


  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


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


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01106677     History of Changes
Other Study ID Numbers: CR017023
28431754DIA3006 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: April 1, 2010
Results First Received: April 4, 2013
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health