Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Monotherapy 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:
NCT00998881
First received: October 15, 2009
Last updated: January 8, 2014
Last verified: January 2014
Results First Received: January 8, 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: Teneligliptin 20 mg
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
Placebo Teneligliptin placebo-matching tablets, orally, once daily
Teneligliptin 20 mg Teneligliptin 20 mg, orally, once daily

Participant Flow:   Overall Study
    Placebo     Teneligliptin 20 mg  
STARTED     104     99  
COMPLETED     96     97  
NOT COMPLETED     8     2  
Adverse Event                 2                 2  
Lack of Efficacy                 1                 0  
Physician Decision                 3                 0  
Withdrawal by Subject                 1                 0  
Personal matter                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Placebo Teneligliptin placebo-matching tablets, orally, once daily
Teneligliptin 20 mg Teneligliptin 20 mg, orally, once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Teneligliptin 20 mg     Total  
Number of Participants  
[units: participants]
  104     99     203  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 10.1     58.5  ± 10.0     58.9  ± 10.0  
Gender  
[units: participants]
     
Female     34     31     65  
Male     70     68     138  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c at Week 12   [ Time Frame: 12 weeks ]

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

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: 12 weeks ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT00998881     History of Changes
Other Study ID Numbers: 3000-A5
Study First Received: October 15, 2009
Results First Received: January 8, 2014
Last Updated: January 8, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare