A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01863667
First received: May 23, 2013
Last updated: December 15, 2015
Last verified: December 2015
Results First Received: September 29, 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 Mellitus
Interventions: Drug: Omarigliptin
Drug: Glimepiride
Drug: Omarigliptin Placebo
Drug: Glimepiride 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had a 1-week Screening Period; an oral antihyperglycemic agent (AHA) “wash-off” period of 8 weeks for participants on oral AHAs; a 2-week single-blind placebo run-in period; and a 54-week double-blind treatment period.

Reporting Groups
  Description
Omarigliptin Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
Glimepiride Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.

Participant Flow:   Overall Study
    Omarigliptin     Glimepiride  
STARTED     33     32  
COMPLETED     0     0  
NOT COMPLETED     33     32  
Adverse Event                 1                 0  
Study terminated by Sponsor                 30                 30  
Withdrawal by Subject                 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
Omarigliptin Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
Glimepiride Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
Total Total of all reporting groups

Baseline Measures
    Omarigliptin     Glimepiride     Total  
Number of Participants  
[units: participants]
  33     32     65  
Age  
[units: Years]
Mean (Standard Deviation)
  58.0  (14.1)     56.8  (9.9)     57.4  (12.1)  
Gender  
[units: Participants]
     
Female     19     16     35  
Male     14     16     30  



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

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Up to 57 weeks (including 3 weeks following the last dose of study drug) ]

3.  Primary:   Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 54 weeks ]

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

5.  Secondary:   Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment   [ Time Frame: 54 weeks ]

6.  Secondary:   Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment   [ Time Frame: 54 weeks ]

7.  Secondary:   Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia   [ Time Frame: Up to 54 weeks ]

8.  Secondary:   Change From Baseline in Body Weight at Week 54   [ Time Frame: Baseline and 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
The study was terminated based on business decisions only, and not due to any unexpected safety or efficacy concerns.


  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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01863667     History of Changes
Other Study ID Numbers: 3102-027
2013-000301-23 ( EudraCT Number )
Study First Received: May 23, 2013
Results First Received: September 29, 2015
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration