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A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)

This study has been terminated.
(Study was terminated due to inability to recruit patients.)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00846391
First received: February 17, 2009
Last updated: June 3, 2011
Last verified: June 2011
Results First Received: August 26, 2010  
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: MK8245 5 mg (twice a day) b.i.d.
Drug: MK8245 50 mg b.i.d.
Drug: 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

First Patient In:10-Feb-2009 Early Termination*:11-Aug-2009 Last Patient Last Visit:19-Aug-2009 10 Centers Worldwide

*Study was terminated due to inability to recruit patients. Because it was not terminated for safety concerns, sites were to see patients for early termination visit at earliest convenience. The last patient was seen 19-Aug-2009.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 18-65 yrs not on antihyperglycemic agent (AHA) (A1C 7-10%),or single AHA (A1C 7-9.5%),or low dose dual AHA therapy (A1C 6.5-9.5%) with type 2 diabetes mellitus entered a 4-wk diet/exercise period (AHA wash-off if on AHA),after which,those with fasting glucose of 130-250 mg/dL were eligible for randomization (after a 2 wk pbo run-in period)

Reporting Groups
  Description
MK8245 5 mg b.i.d. Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
MK8245 50 mg b.i.d. Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
Placebo Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.

Participant Flow:   Overall Study
    MK8245 5 mg b.i.d.     MK8245 50 mg b.i.d.     Placebo  
STARTED     4     4     6  
COMPLETED     3     2     3  
NOT COMPLETED     1     2     3  
Physician Decision                 0                 0                 1  
Study Terminated by Sponsor                 1                 2                 2  



  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
MK8245 5 mg b.i.d. Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
MK8245 50 mg b.i.d. Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
Placebo Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
Total Total of all reporting groups

Baseline Measures
    MK8245 5 mg b.i.d.     MK8245 50 mg b.i.d.     Placebo     Total  
Number of Participants  
[units: participants]
  4     4     6     14  
Age  
[units: years]
Mean ± Standard Deviation
  49.8  ± 13.4     55.5  ± 7.7     53.5  ± 7.5     53.0  ± 9.0  
Gender  
[units: participants]
       
Female     2     4     5     11  
Male     2     0     1     3  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     2     2     3     7  
Not Hispanic or Latino     2     2     3     7  
Unknown or Not Reported     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
       
Black OR African American     0     0     1     1  
Multi-Racial     1     0     0     1  
White     3     4     5     12  



  Outcome Measures

1.  Primary:   Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4   [ Time Frame: Baseline and Week 4 ]


  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
This study was terminated due to the continuing inability to recruit patients. No efficacy analysis was performed because of insufficient sample size for meaningful analysis due to early study termination and insufficient sample size.


  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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00846391     History of Changes
Other Study ID Numbers: MK8245-005, 2009_541
Study First Received: February 17, 2009
Results First Received: August 26, 2010
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration