Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00974090
First received: September 8, 2009
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: April 7, 2014  
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: Type 2 Diabetes Mellitus
Interventions: Drug: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea)
Drug: Teneli / Teneli + SU

  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
Placebo / Teneli + SU Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
Teneli / Teneli + SU Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride

Participant Flow for 2 periods

Period 1:   Period 1: Double Blind Period
    Placebo / Teneli + SU     Teneli / Teneli + SU  
STARTED     98     96  
COMPLETED     95     95  
NOT COMPLETED     3     1  
Adverse Event                 2                 1  
Physician Decision                 1                 0  

Period 2:   Period 2: Open-label Period
    Placebo / Teneli + SU     Teneli / Teneli + SU  
STARTED     95     95  
COMPLETED     87     85  
NOT COMPLETED     8     10  
Adverse Event                 4                 6  
Lack of Efficacy                 3                 1  
Physician Decision                 0                 3  
Withdrawal by Subject                 1                 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
Placebo / Teneli + SU Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
Teneli / Teneli + SU Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
Total Total of all reporting groups

Baseline Measures
    Placebo / Teneli + SU     Teneli / Teneli + SU     Total  
Number of Participants  
[units: participants]
  98     96     194  
Age  
[units: years]
Mean ± Standard Deviation
  60.3  ± 7.8     58.4  ± 8.6     59.4  ± 8.2  
Gender  
[units: participants]
     
Female     32     34     66  
Male     66     62     128  



  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c at Week 12   [ Time Frame: at Week 0 and Week 12 ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 12   [ Time Frame: at Week 0 and Week 12 ]

3.  Secondary:   Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12   [ Time Frame: 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12 ]

4.  Secondary:   Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12   [ Time Frame: at Week 0 and Week 12 ]


  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:

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00974090     History of Changes
Other Study ID Numbers: 3000-A6
Study First Received: September 8, 2009
Results First Received: April 7, 2014
Last Updated: April 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare