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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01387737
First Posted: July 6, 2011
Last Update Posted: June 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
Results First Submitted: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
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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.
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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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in Body Weight   [ Time Frame: Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in Blood Pressure   [ Time Frame: Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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