A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01717313
First received: October 26, 2012
Last updated: June 10, 2016
Last verified: June 2016
Results First Received: May 9, 2016  
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: Placebo to Omarigliptin
Drug: Metformin
Drug: Placebo to metformin
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The double-blind treatment period included a 24-week placebo-controlled (omarigliptin/omarigliptin-matching placebo) period (Phase A) and a 30-week active-controlled period with blinded metformin/metformin matching placebo (Phase B).

Reporting Groups
  Description
Omarigliptin Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
Placebo to Omarigliptin Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.

Participant Flow for 3 periods

Period 1:   Phase A (Weeks 0 to 24)
    Omarigliptin     Placebo to Omarigliptin  
STARTED     165     164  
COMPLETED     147     151  
NOT COMPLETED     18     13  
Death                 0                 1  
Lost to Follow-up                 1                 3  
Withdrawal by Subject                 12                 6  
Adverse Event                 4                 2  
Non-Compliance with Study Drug                 1                 1  

Period 2:   Interphase
    Omarigliptin     Placebo to Omarigliptin  
STARTED     147     151  
COMPLETED     146     151  
NOT COMPLETED     1     0  
Completed Phase A Did Not Enter Phase B                 1                 0  

Period 3:   Phase B (Weeks 24 to 54)
    Omarigliptin     Placebo to Omarigliptin  
STARTED     146     151  
COMPLETED     134     135  
NOT COMPLETED     12     16  
Study Terminated by Sponsor                 4                 4  
Withdrawal by Subject                 7                 9  
Lost to Follow-up                 1                 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.
No text entered.

Reporting Groups
  Description
Omarigliptin Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
Placebo to Omarigliptin Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
Total Total of all reporting groups

Baseline Measures
    Omarigliptin     Placebo to Omarigliptin     Total  
Number of Participants  
[units: participants]
  165     164     329  
Age  
[units: Years]
Mean (Standard Deviation)
  57.4  (9.2)     57.0  (9.7)     57.2  (9.5)  
Gender  
[units: Participants]
     
Female     70     67     137  
Male     95     97     192  



  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population)   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)   [ Time Frame: Up to 27 weeks ]

3.  Primary:   Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)   [ Time Frame: Up to 24 weeks ]

4.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)   [ Time Frame: Up to 57 weeks ]

5.  Primary:   Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)   [ Time Frame: Up to 57 weeks ]

6.  Secondary:   Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population)   [ Time Frame: Week 24 ]

7.  Secondary:   Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population)   [ Time Frame: Week 24 ]

8.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population)   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:   Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population)   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population)   [ Time Frame: Baseline and Week 54 ]

11.  Secondary:   Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 54 (Phase A + Phase B, FAS Population)   [ Time Frame: Week 54 ]

12.  Secondary:   Percentage of Participants Who Achieve an A1C Goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population)   [ Time Frame: Week 54 ]

13.  Secondary:   Change From Baseline in FPG at Week 54 (Phase A + Phase B, FAS Population)   [ Time Frame: Baseline and Week 54 ]

14.  Post-Hoc:   Change From Baseline in A1C at Week 24 (Phase A, Per-Protocol Population)   [ Time Frame: Baseline and Week 24 ]

15.  Post-Hoc:   Change From Baseline in FPG at Week 24 (Phase A, Per-Protocol Population)   [ Time Frame: Baseline and Week 24 ]

16.  Post-Hoc:   Change From Baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population)   [ 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
Care must be taken in the interpretation of the results in this study as the non-protocol-specified prohibited use of metformin among a number of participants may have impacted the safety and efficacy results disproportionally among study arms.


  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: NCT01717313     History of Changes
Other Study ID Numbers: 3102-011
2012-003626-24 ( EudraCT Number )
Study First Received: October 26, 2012
Results First Received: May 9, 2016
Last Updated: June 10, 2016
Health Authority: United States: Food and Drug Administration