Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01939496
First received: September 6, 2013
Last updated: March 8, 2016
Last verified: March 2016
Results First Received: March 8, 2016  
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
Hypertension
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 504 participants were screened. Of which, 171 participants were randomized to study treatment. 2 participants were randomized but not dosed.

Reporting Groups
  Description
Placebo Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Canagliflozin 100 Milligram (mg) Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Canagliflozin 300 mg Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.

Participant Flow:   Overall Study
    Placebo     Canagliflozin 100 Milligram (mg)     Canagliflozin 300 mg  
STARTED     56     57     56  
COMPLETED     47     54     54  
NOT COMPLETED     9     3     2  
Adverse Event                 2                 0                 0  
Lost to Follow-up                 1                 1                 0  
Physician Decision                 1                 0                 0  
Protocol Violation                 3                 0                 0  
Withdrawal by Subject                 0                 1                 1  
Blood Pressure Withdrawal Criteria                 0                 1                 0  
Unspecified                 2                 0                 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.
The full analysis set included all randomized participants who took at least 1 dose of double blind study medication.

Reporting Groups
  Description
Placebo Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
Canagliflozin 100 Milligram (mg) Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
Canagliflozin 300 mg Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Canagliflozin 100 Milligram (mg)     Canagliflozin 300 mg     Total  
Number of Participants  
[units: participants]
  56     57     56     169  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     38     46     45     129  
>=65 years     18     11     11     40  
Age  
[units: years]
Mean (Standard Deviation)
  59.6  (9.52)     57.8  (8.74)     58.3  (6.88)     58.6  (8.44)  
Gender  
[units: participants]
       
Female     23     23     25     71  
Male     33     34     31     98  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:   Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2   [ Time Frame: Baseline and Day 2 ]

3.  Secondary:   Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

4.  Secondary:   Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

5.  Secondary:   Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

6.  Secondary:   Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

7.  Secondary:   Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6   [ Time Frame: Baseline, Day 2 and Week 6 ]

8.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6   [ Time Frame: Baseline and Week 6 ]

9.  Secondary:   Change From Baseline in Body Weight to Week 6   [ Time Frame: Baseline and Week 6 ]

10.  Secondary:   Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

11.  Secondary:   Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

12.  Secondary:   Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

13.  Secondary:   Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

14.  Secondary:   Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]

15.  Secondary:   Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6   [ Time Frame: Baseline, Day 2, Week 3 and 6 ]


  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: Senior Director
Organization: Janssen Scientific Affairs, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01939496     History of Changes
Other Study ID Numbers: CR102208
28431754DIA4002 ( Other Identifier: Janssen Scientific Affairs, LLC )
Study First Received: September 6, 2013
Results First Received: March 8, 2016
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government