Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01387737
First received: June 28, 2011
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: TA-7284-Low
Drug: TA-7284-High

  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
No text entered.

Reporting Groups
  Description
TA-7284-Low TA-7284 low dose, once daily for 52 weeks
TA-7284-High TA-7284 high dose, once daily for 52 weeks

Participant Flow:   Overall Study
    TA-7284-Low     TA-7284-High  
STARTED     584     715  
COMPLETED     532     641  
NOT COMPLETED     52     74  
Adverse Event                 20                 30  
Lack of Efficacy                 1                 0  
Physician Decision                 3                 10  
Withdrawal by Subject                 27                 31  
Clearly not eligible for the study                 1                 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
TA-7284-Low TA-7284 low dose, once daily for 52 weeks
TA-7284-High TA-7284 high dose, once daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
    TA-7284-Low     TA-7284-High     Total  
Number of Participants  
[units: participants]
  584     715     1299  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     436     520     956  
>=65 years     148     195     343  
Gender  
[units: participants]
     
Female     163     212     375  
Male     421     503     924  



  Outcome Measures

1.  Primary:   Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events   [ Time Frame: 54 weeks ]

2.  Secondary:   Change in HbA1c   [ Time Frame: Week 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: Week 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in Body Weight   [ Time Frame: Week 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Blood Pressure   [ Time Frame: Week 52 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


No publications provided


Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01387737     History of Changes
Other Study ID Numbers: TA-7284-06
Study First Received: June 28, 2011
Results First Received: March 26, 2014
Last Updated: May 27, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare