Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00972322
First received: September 3, 2009
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: May 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: MK-8245
Drug: Comparator: placebo

  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
This was a multicenter study in 5 clinical centers in the United States.

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
MK-8245 100 mg MK-8245, 50 mg, twice daily for 28 days
Placebo Placebo to MK-8245, twice daily for 28 days

Participant Flow:   Overall Study
    MK-8245 100 mg     Placebo  
STARTED     28     28  
COMPLETED     25     25  
NOT COMPLETED     3     3  
Adverse Event                 2                 1  
Positive drug screen                 0                 1  
Lost to Follow-up                 0                 1  
Consistently high glucose values                 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.
No text entered.

Reporting Groups
  Description
MK-8245 100 mg MK-8245, 50 mg, twice daily for 28 days
Placebo Placebo to MK-8245, twice daily for 28 days
Total Total of all reporting groups

Baseline Measures
    MK-8245 100 mg     Placebo     Total  
Number of Participants  
[units: participants]
  28     28     56  
Age  
[units: Years]
Mean ± Standard Deviation
  54.7  ± 8.53     52.7  ± 7.30     53.7  ± 7.93  
Gender  
[units: Participants]
     
Female     12     12     24  
Male     16     16     32  



  Outcome Measures
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1.  Primary:   Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)   [ Time Frame: Baseline and Day 28 ]

2.  Primary:   Number of Participants Who Experienced Serious or Non-serious Adverse Events   [ Time Frame: Up to Day 31 ]

3.  Primary:   Number of Participants Discontinuing Study Drug Due to an AE   [ Time Frame: Up to Day 28 ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00972322     History of Changes
Other Study ID Numbers: 8245-012, MK-8245-012, 2009_655
Study First Received: September 3, 2009
Results First Received: May 14, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration