A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01814748
First received: March 18, 2013
Last updated: June 7, 2016
Last verified: June 2016
Results First Received: June 7, 2016  
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
Interventions: Drug: Omarigliptin
Drug: Placebo to omarigliptin
Drug: 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
No text entered.

Reporting Groups
  Description
Omarigliptin 25 mg Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Placebo Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Participant Flow:   Overall Study
    Omarigliptin 25 mg     Placebo  
STARTED     102     101  
COMPLETED     94     94  
NOT COMPLETED     8     7  
Lost to Follow-up                 1                 2  
Study site terminated by sponsor                 1                 1  
Withdrawal by Subject                 6                 4  



  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
Omarigliptin 25 mg Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Placebo Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
Total Total of all reporting groups

Baseline Measures
    Omarigliptin 25 mg     Placebo     Total  
Number of Participants  
[units: participants]
  102     101     203  
Age  
[units: Years]
Mean (Standard Deviation)
  38.8  (4.7)     39.5  (4.5)     39.2  (4.6)  
Gender  
[units: Participants]
     
Female     35     41     76  
Male     67     60     127  
Hemoglobin A1c (A1C)  
[units: Percent]
Mean (Standard Deviation)
  7.9  (0.8)     8.1  (0.9)     8.0  (0.8)  
2-hour post-meal glucose (2-hr PMG) [1]
[units: mg/dL]
Mean (Standard Deviation)
  204.9  (55.1)     217.3  (67.7)     211.2  (62.0)  
Fasting plasma glucose (FPG)  
[units: mg/dL]
Mean (Standard Deviation)
  164.0  (38.9)     167.8  (40.6)     165.9  (39.7)  
[1] Omarigliptin, n=98; placebo, n=101; Total, n=199



  Outcome Measures
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1.  Primary:   Change From Baseline in A1C at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event (AE)   [ Time Frame: Up to Week 27 ]

3.  Primary:   Percentage of Participants Who Discontinued Study Drug Due to an AE   [ Time Frame: Up to Week 24 ]

4.  Secondary:   Change From Baseline in 2-hr PMG at Week 24   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Change in Baseline in FPG at Week 24   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Percentage of Participants Attaining A1C Glycemic Goals of <7.0% at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:   Percentage of Participants Attaining A1C Glycemic Goals of <6.5% at Week 24   [ Time Frame: Week 24 ]

8.  Secondary:   Percentage of Participants Who Required Glycemic Rescue by Week 24   [ Time Frame: Up to Week 24 ]


  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
Investigations indicate that the presence of metformin in future biomedical research (FBR) samples from non-rescued participants was due to participant self-administration of metformin outside of the protocol and without investigator knowledge.


  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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01814748     History of Changes
Other Study ID Numbers: 3102-028
2012-004303-12 ( EudraCT Number )
Study First Received: March 18, 2013
Results First Received: June 7, 2016
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration