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A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01809327
First received: March 8, 2013
Last updated: January 14, 2016
Last verified: January 2016
Results First Received: December 1, 2015  
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
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Canagliflozin 100 mg
Drug: Canagliflozin 300 mg
Drug: Metformin XR

  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
The study was conducted between 16 May 2013 and 01 December 2014 and recruited participants from 158 study centers in 12 countries worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1,186 participants were randomly allocated to the 5 treatment arms. All participants received at least 1 dose of study drug and were included in the modified intent-to-treat (mITT) analysis set.

Reporting Groups
  Description
Metformin XR Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
Canagliflozin 100 Milligram (mg) Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
Canagliflozin 300 mg Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
Canagliflozin 100 mg + Metformin XR Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Canagliflozin 300 mg + Metformin XR Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.

Participant Flow:   Overall Study
    Metformin XR   Canagliflozin 100 Milligram (mg)   Canagliflozin 300 mg   Canagliflozin 100 mg + Metformin XR   Canagliflozin 300 mg + Metformin XR
STARTED   237   237   238   237   237 
COMPLETED   205   211   216   225   212 
NOT COMPLETED   32   26   22   12   25 
Lost to Follow-up                5                2                4                2                3 
Withdrawal by Subject                6                4                4                2                5 
Adverse Event                4                3                7                4                8 
Death                1                0                0                0                0 
Protocol Violation                0                1                0                0                0 
Physician Decision                1                1                0                0                0 
Pregnancy                1                0                0                0                0 
Unspecified                14                15                7                4                9 



  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
Metformin XR Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
Canagliflozin 100 Milligram (mg) Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
Canagliflozin 300 mg Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
Canagliflozin 100 mg + Metformin XR Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Canagliflozin 300 mg + Metformin XR Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
Total Total of all reporting groups

Baseline Measures
   Metformin XR   Canagliflozin 100 Milligram (mg)   Canagliflozin 300 mg   Canagliflozin 100 mg + Metformin XR   Canagliflozin 300 mg + Metformin XR   Total 
Overall Participants Analyzed 
[Units: Participants]
 237   237   238   237   237   1186 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (9.75)   54.0  (10.70)   55.8  (9.56)   54.2  (9.58)   55.4  (9.84)   54.9  (9.91) 
Gender 
[Units: Participants]
           
Female   121   132   113   129   122   617 
Male   116   105   125   108   115   569 
Region of Enrollment 
[Units: Participants]
           
Argentina   12   19   21   17   20   89 
Brazil   1   2   1   0   0   4 
Czech Republic   8   6   6   6   8   34 
Hungary   2   5   8   9   4   28 
Mexico   33   31   19   38   38   159 
Romania   24   16   21   27   14   102 
Russian Federation   38   38   45   44   37   202 
Slovakia   17   12   22   9   9   69 
South Africa   5   5   4   5   3   22 
South Korea   4   2   2   1   3   12 
Ukraine   50   56   42   40   54   242 
United States   43   45   47   41   47   223 


  Outcome Measures
  Show All Outcome Measures

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

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

3.  Secondary:   Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26   [ Time Frame: Week 26 ]

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

5.  Secondary:   Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26   [ Time Frame: Day 1 (Baseline) and Week 26 ]

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

7.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (AEs)   [ Time Frame: Up to 30 weeks of last study drug administration ]


  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 Clinical Research
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


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

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01809327     History of Changes
Other Study ID Numbers: CR100034
28431754DIA3011 ( Other Identifier: Janssen Research & Development, LLC )
2011-000400-17 ( EudraCT Number )
Study First Received: March 8, 2013
Results First Received: December 1, 2015
Last Updated: January 14, 2016
Health Authority: United States: Food and Drug Administration
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Federal Government