Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01301833
First received: February 14, 2011
Last updated: July 31, 2015
Last verified: April 2013
Results First Received: July 31, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Teneli
Drug: Teneli + Glin
Drug: Teneli + BG
Drug: Teneli + A-GI

  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
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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
Teneli Teneligliptin
Teneli + Glin Teneligliptin plus glinide
Teneli + BG Teneligliptin plus biguanide
Teneli + A-GI Teneligliptin plus alpha-glucosidase inhibitor

Participant Flow:   Overall Study
    Teneli     Teneli + Glin     Teneli + BG     Teneli + A-GI  
STARTED     212     80     95     75  
COMPLETED     197     72     88     68  
NOT COMPLETED     15     8     7     7  
Adverse Event                 7                 5                 5                 5  
Lack of Efficacy                 1                 1                 0                 0  
Physician Decision                 3                 1                 1                 0  
Withdrawal by Subject                 3                 1                 1                 2  
Personal matter                 1                 0                 0                 0  



  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
Teneli Teneligliptin
Teneli + Glin Teneligliptin plus glinide
Teneli + BG Teneligliptin plus biguanide
Teneli + A-GI Teneligliptin plus alpha-glucosidase inhibitor
Total Total of all reporting groups

Baseline Measures
    Teneli     Teneli + Glin     Teneli + BG     Teneli + A-GI     Total  
Number of Participants  
[units: participants]
  212     80     95     75     462  
Age, Customized  
[units: participants]
         
<65 years     141     45     66     39     291  
>=65 years     71     35     29     36     171  
Gender  
[units: participants]
         
Female     71     31     37     25     164  
Male     141     49     58     50     298  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 52 Weeks ]

2.  Secondary:   Change From Baseline in HbA1c at Week 52   [ Time Frame: 52 Weeks ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 52   [ Time Frame: 52 Weeks ]

4.  Secondary:   Change From Baseline in Fasting Glucagon at Week 52   [ Time Frame: 52 Weeks ]

5.  Secondary:   Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52   [ Time Frame: 52 Weeks ]


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


Publications of Results:

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01301833     History of Changes
Other Study ID Numbers: 3000-A14
Study First Received: February 14, 2011
Results First Received: July 31, 2015
Last Updated: July 31, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare