Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01841697
First received: April 24, 2013
Last updated: March 2, 2016
Last verified: March 2016
Results First Received: October 23, 2015  
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
Interventions: Drug: Omarigliptin
Drug: Sitagliptin
Drug: Placebo to omarigliptin
Drug: Placebo to Sitagliptin
Drug: Open-label Metformin
Drug: Open-label Glimepiride

  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
Omarigliptin 25 mg Once Weekly Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Sitagliptin 100 mg Once Daily Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.

Participant Flow:   Overall Study
    Omarigliptin 25 mg Once Weekly     Sitagliptin 100 mg Once Daily  
STARTED     322     320  
COMPLETED     302     302  
NOT COMPLETED     20     18  
Death                 0                 1  
Lost to Follow-up                 4                 1  
Withdrawal by Subject                 16                 16  



  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
Omarigliptin 25 mg Once Weekly Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Sitagliptin 100 mg Once Daily Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Total Total of all reporting groups

Baseline Measures
    Omarigliptin 25 mg Once Weekly     Sitagliptin 100 mg Once Daily     Total  
Number of Participants  
[units: participants]
  322     320     642  
Age  
[units: Years]
Mean (Standard Deviation)
  57.0  (9.8)     57.6  (9.8)     57.3  (9.8)  
Gender  
[units: Participants]
     
Female     171     145     316  
Male     151     175     326  
Hemoglobin A1c (A1C)  
[units: Percent]
Mean (Standard Deviation)
  7.52  (0.77)     7.49  (0.74)     7.50  (0.76)  
Fasting plasma glucose (FPG)  
[units: mg/dL]
Mean (Standard Deviation)
  160.1  (35.7)     153.9  (32.8)     157.0  (34.4)  



  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   [ Time Frame: Up to 27 weeks (including 3-week follow-up) ]

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

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

5.  Secondary:   Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment   [ Time Frame: Week 24 ]

6.  Secondary:   Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment   [ Time Frame: 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
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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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01841697     History of Changes
Other Study ID Numbers: 3102-026
2013-000059-42 ( EudraCT Number )
Study First Received: April 24, 2013
Results First Received: October 23, 2015
Last Updated: March 2, 2016
Health Authority: United States: Food and Drug Administration