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Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00497198
First received: July 5, 2007
Last updated: June 3, 2012
Last verified: June 2012
History of Changes
Results First Received: July 14, 2011  
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
Interventions: Drug: MCI-196
Drug: Placebo of MCI-196 Tablet

  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
MCI-196 Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
Placebo Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Participant Flow:   Overall Study
    MCI-196     Placebo  
STARTED     92     91  
COMPLETED     87     86  
NOT COMPLETED     5     5  
Adverse Event                 4                 2  
Physician Decision                 1                 2  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
MCI-196 Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
Placebo Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Total Total of all reporting groups

Baseline Measures
    MCI-196     Placebo     Total  
Number of Participants  
[units: participants]
 		  92     91     183  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     60     55     115  
>=65 years     32     36     68  
Gender  
[units: participants]
 		     
Female     33     34     67  
Male     59     57     116  



  Outcome Measures
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1.  Primary:   Fasting Plasma Glucose at Baseline   [ Time Frame: 0 weeks ]
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2.  Primary:   Change From Baseline in Blood Glucose at Week 12   [ Time Frame: 12 weeks (baseline to week 12) ]
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3.  Primary:   Hemoglobin A1c (HbA1c) at Baseline   [ Time Frame: 0 weeks ]
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4.  Primary:   Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12   [ Time Frame: 12 weeks (baseline to week 12) ]
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5.  Secondary:   Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12   [ Time Frame: 12 weeks (baseline to week 12) ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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: General Manager, Clinical Research Department II, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00497198     History of Changes
Other Study ID Numbers: MCI196-19
Study First Received: July 5, 2007
Results First Received: July 14, 2011
Last Updated: June 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare