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Dose-Range Finding Study for MK0893 (0893-008)

This study has been terminated.
(Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy)
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00479466
First received: May 25, 2007
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
Results First Received: October 7, 2011  
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: Diabetes Mellitus, Type 2
Interventions: Drug: MK0893
Drug: Metformin
Drug: Placebo to MK0893
Drug: Placebo to Metformin

  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
No text entered.

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 No text entered.
MK0893 20 mg No text entered.
MK0893 40 mg No text entered.
MK0893 60 mg No text entered.
MK0893 80 mg No text entered.
Metformin HCL No text entered.

Participant Flow:   Overall Study
    Placebo     MK0893 20 mg     MK0893 40 mg     MK0893 60 mg     MK0893 80 mg     Metformin HCL  
STARTED     57     57     57     58     56     57  
COMPLETED     44     49     54     55     48     53  
NOT COMPLETED     13     8     3     3     8     4  
Adverse Event                 5                 1                 0                 1                 2                 0  
Hyperglycemia                 0                 0                 0                 0                 0                 1  
Lack of Efficacy                 2                 0                 1                 0                 0                 0  
Lost to Follow-up                 0                 1                 1                 0                 2                 2  
Physician Decision                 2                 1                 1                 0                 0                 0  
Pregnancy                 0                 0                 0                 0                 1                 0  
Protocol Violation                 1                 0                 0                 0                 0                 0  
Withdrawal by Subject                 3                 5                 0                 2                 3                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo No text entered.
MK0893 20 mg No text entered.
MK0893 40 mg No text entered.
MK0893 60 mg No text entered.
MK0893 80 mg No text entered.
Metformin HCL No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     MK0893 20 mg     MK0893 40 mg     MK0893 60 mg     MK0893 80 mg     Metformin HCL     Total  
Number of Participants  
[units: participants]
 		  57     57     57     58     56     57     342  
Age  
[units: years]
Mean ± Standard Deviation 		  54.1  ± 10.2     55.6  ± 8.2     53.7  ± 8.2     56.1  ± 7.9     53.5  ± 10.4     55.1  ± 8.2     54.7  ± 8.9  
Gender  
[units: participants]
 		             
Female     31     28     22     26     31     30     168  
Male     26     29     35     32     25     27     174  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)   [ Time Frame: Week 12 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)   [ Time Frame: Week 12 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)   [ Time Frame: Week 12 ]
  Show Outcome Measure 3


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy, thus the study was discontinued.  


Results Point of Contact:  
Name/Title: Vice President of Late Stage Development, Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00479466     History of Changes
Other Study ID Numbers: MK-0893-008, 2007_526
Study First Received: May 25, 2007
Results First Received: October 7, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration