Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01703221
First received: October 5, 2012
Last updated: June 24, 2016
Last verified: June 2016
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, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Omarigliptin
Drug: Sitagliptin
Drug: Placebo to omarigliptin
Drug: Placebo to sitagliptin

  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
Forty-eight sites in Japan received IRB approval and were shipped clinical supplies in this study and randomized at least one participant. One hundred and seventeen participants were not randomized; the most common reason for participants not being randomized was screen failure.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Phase A, participants were randomized to receive either omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo for 24 weeks in a blinded manner. In Phase B, all participants received open-label omarigliptin 25 mg once weekly for 28 weeks.

Reporting Groups
  Description
Omarigliptin (Phase A+B) Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
Sitagliptin (Phase A) Switching to Omarigliptin (Phase B) Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Placebo (Phase A) Switching to Omarigliptin (Phase B) Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Participant Flow for 2 periods

Period 1:   Phase A (Up to 24 Weeks)
    Omarigliptin (Phase A+B)     Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)     Placebo (Phase A) Switching to Omarigliptin (Phase B)  
STARTED     166     165     83  
COMPLETED     159     161     80  
NOT COMPLETED     7     4     3  
Adverse Event                 2                 4                 0  
Lack of Efficacy                 2                 0                 1  
Physician Decision                 1                 0                 0  
Withdrawal by Subject                 2                 0                 1  
Protocol Violation                 0                 0                 1  

Period 2:   Phase B - (Week 25 to 52)
    Omarigliptin (Phase A+B)     Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)     Placebo (Phase A) Switching to Omarigliptin (Phase B)  
STARTED     159     161     80  
COMPLETED     143     147     75  
NOT COMPLETED     16     14     5  
Withdrawal by Subject                 2                 1                 0  
Adverse Event                 2                 3                 2  
Lack of Efficacy                 12                 10                 3  



  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 (Phase A+B) Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
Sitagliptin (Phase A) Switching to Omarigliptin (Phase B) Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Placebo (Phase A) Switching to Omarigliptin (Phase B) Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Total Total of all reporting groups

Baseline Measures
    Omarigliptin (Phase A+B)     Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)     Placebo (Phase A) Switching to Omarigliptin (Phase B)     Total  
Number of Participants  
[units: participants]
  166     165     83     414  
Age  
[units: Years]
Mean (Standard Deviation)
  60  (11)     60  (9)     61  (9)     60  (10)  
Gender  
[units: Participants]
       
Female     62     50     26     138  
Male     104     115     57     276  



  Outcome Measures
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1.  Primary:   Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event During Phase A   [ Time Frame: Up to 24 weeks ]

3.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study   [ Time Frame: Up to 52 weeks ]

4.  Primary:   Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A   [ Time Frame: Up to 24 weeks ]

5.  Primary:   Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study   [ Time Frame: Up to 52 weeks ]

6.  Secondary:   Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24   [ Time Frame: Baseline and 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: NCT01703221     History of Changes
Other Study ID Numbers: 3102-020
132239 ( Registry Identifier: JAPIC-CTI )
Study First Received: October 5, 2012
Results First Received: September 29, 2015
Last Updated: June 24, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency