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Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01088711
First received: March 16, 2010
Last updated: May 12, 2016
Last verified: May 2016
Results First Received: September 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes (T2D)
Interventions: Drug: Omarigliptin
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
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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
Healthy Participants - Omarigliptin Obese healthy participants received once-weekly omarigliptin for 4 weeks.
Healthy - Placebo Obese healthy participants received once-weekly placebo for 4 weeks.
T2D - Omarigliptin Obese T2D participants received once-weekly omarigliptin for 4 weeks.
T2D - Placebo Obese T2D participants received once-weekly placebo for 4 weeks.

Participant Flow:   Overall Study
    Healthy Participants - Omarigliptin     Healthy - Placebo     T2D - Omarigliptin     T2D - Placebo  
STARTED     18     6     6     2  
COMPLETED     18     6     6     2  
NOT COMPLETED     0     0     0     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.
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Reporting Groups
  Description
Healthy Participants - Omarigliptin Obese healthy participants received once-weekly omarigliptin for 4 weeks.
T2D Participants (Panel B) Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks.
T2D - Omarigliptin Obese T2D participants received once-weekly omarigliptin for 4 weeks.
T2D - Placebo Obese T2D participants received once-weekly placebo for 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Healthy Participants - Omarigliptin     T2D Participants (Panel B)     T2D - Omarigliptin     T2D - Placebo     Total  
Number of Participants  
[units: participants]
  18     6     6     2     32  
Age  
[units: Years]
Mean (Standard Deviation)
  52.3  (5.1)     56.2  (7.6)     55.4  (4.4)     61.0  (8.5)     54.2  (5.9)  
Gender  
[units: Participants]
         
Female     12     4     3     1     20  
Male     6     2     3     1     12  



  Outcome Measures
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1.  Primary:   Number of Participants Experiencing an Adverse Event (AE)   [ Time Frame: Up to Day 36 ]

2.  Primary:   Number of Participants Withdrawing From Study Therapy Due to an AE   [ Time Frame: Up to Day 22 ]

3.  Secondary:   Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15   [ Time Frame: 168 hours post-dose on Day 15 ]

4.  Secondary:   Percent Inhibition of DPP-4 After Day 22   [ Time Frame: 168 hours post dose on Day 22 ]

5.  Secondary:   WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration   [ Time Frame: Through 4 hours post dose on Day 21 ]

6.  Secondary:   WAA Total GLP-1 Concentration   [ Time Frame: Through 4 hours post dose on Day 21 ]

7.  Secondary:   Plasma Glucose Concentration   [ Time Frame: Through 4 hours post dose on Day 21 ]


  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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01088711     History of Changes
Other Study ID Numbers: 3102-004
Study First Received: March 16, 2010
Results First Received: September 29, 2015
Last Updated: May 12, 2016
Health Authority: United States: Food and Drug Administration