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A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01682759
First received: September 7, 2012
Last updated: January 6, 2016
Last verified: December 2015
Results First Received: January 6, 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: Type 2 Diabetes Mellitus
Interventions: Drug: Omarigliptin
Drug: Placebo to Omarigliptin
Drug: Glimepiride
Drug: Glimepiride Placebo
Drug: Metformin
Drug: Insulin Glargine

  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
In total, 1197 participants at 115 clinical sites were screened and 446 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were participants not meeting the metformin inclusion criteria or meeting exclusionary laboratory values.

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 Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
Glimepiride Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

Participant Flow:   Overall Study
    Omarigliptin     Glimepiride  
STARTED     376     375  
Treated     375     375  
COMPLETED     307     305  
NOT COMPLETED     69     70  
Death                 2                 1  
Lost to Follow-up                 10                 13  
Physician Decision                 1                 1  
Withdrawal by Subject                 56                 55  



  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 Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
Glimepiride Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
Total Total of all reporting groups

Baseline Measures
    Omarigliptin     Glimepiride     Total  
Number of Participants  
[units: participants]
  376     375     751  
Age  
[units: years]
Mean (Standard Deviation)
  57.9  (9.6)     57.6  (9.3)     57.7  (9.5)  
Gender  
[units: Participants]
     
Female     173     164     337  
Male     203     211     414  
Hemoglobin A1C [1]
[units: A1C (%)]
Mean (Standard Deviation)
  7.49  (0.75)     7.43  (0.72)     7.46  (0.73)  
Fasting Plamsa Glucose (FPG) [1]
[units: mg/dL]
Mean (Standard Deviation)
  155.3  (31.4)     152.7  (30.0)     154.0  (30.7)  
Body Weight [1]
[units: kg]
Mean (Standard Deviation)
  87.5  (18.1)     88.7  (18.7)     88.1  (18.4)  
[1] For both the Omarigliptin and Glimepiride groups n=375



  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1C at Week 54   [ Time Frame: Baseline and Week 54 ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue   [ Time Frame: Up to Week 57 ]

3.  Primary:   Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue   [ Time Frame: Up to Week 54 ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 54   [ Time Frame: Baseline and Week 54 ]

5.  Secondary:   Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54   [ Time Frame: Week 54 ]

6.  Secondary:   Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue   [ Time Frame: Up to Week 54 ]

7.  Secondary:   Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue   [ Time Frame: Baseline and Week 54 ]

8.  Secondary:   Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54   [ Time Frame: Week 54 ]


  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: NCT01682759     History of Changes
Other Study ID Numbers: 3102-016
MK-3102-016 ( Other Identifier: protocol number )
Study First Received: September 7, 2012
Results First Received: January 6, 2016
Last Updated: January 6, 2016
Health Authority: United States: Food and Drug Administration