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A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01217073
First received: October 6, 2010
Last updated: November 25, 2015
Last verified: November 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, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Omarigliptin
Drug: Placebo to omarigliptin
Drug: Pioglitazone
Drug: Metformin
Drug: Placebo to metformin

  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 0.25 mg (Base) Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
Omarigliptin 1 mg (Base) Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Pooled Omarigliptin (Extension) Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)
Placebo/Metformin (Extension) Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day

Participant Flow for 2 periods

Period 1:   Base Period
    Omarigliptin 0.25 mg (Base)     Omarigliptin 1 mg (Base)     Omarigliptin 3 mg (Base)     Omarigliptin 10 mg (Base)     Omarigliptin 25 mg (Base)     Placebo (Base)     Pooled Omarigliptin (Extension)     Placebo/Metformin (Extension)  
STARTED     113     115     114     115     114     114     0     0  
COMPLETED     106     110     107     113     99     105     0     0  
NOT COMPLETED     7     5     7     2     15     9     0     0  
Adverse Event                 1                 0                 1                 0                 4                 1                 0                 0  
Alanine aminotransferase (ALT)/AST                 1                 0                 0                 0                 0                 0                 0                 0  
Excluded medication                 0                 0                 0                 0                 1                 0                 0                 0  
Lack of Efficacy                 0                 0                 0                 0                 0                 1                 0                 0  
Lost to Follow-up                 0                 0                 1                 1                 3                 0                 0                 0  
Physician Decision                 0                 0                 0                 0                 1                 0                 0                 0  
Protocol Violation                 1                 0                 0                 0                 1                 2                 0                 0  
Withdrawal by Subject                 4                 5                 5                 1                 5                 5                 0                 0  

Period 2:   Extension Period
    Omarigliptin 0.25 mg (Base)     Omarigliptin 1 mg (Base)     Omarigliptin 3 mg (Base)     Omarigliptin 10 mg (Base)     Omarigliptin 25 mg (Base)     Placebo (Base)     Pooled Omarigliptin (Extension)     Placebo/Metformin (Extension)  
STARTED     0     0     0     0     0     0     405     80  
COMPLETED     0     0     0     0     0     0     314     60  
NOT COMPLETED     0     0     0     0     0     0     91     20  
Adverse Event                 0                 0                 0                 0                 0                 0                 19                 5  
ALT/AST                 0                 0                 0                 0                 0                 0                 2                 0  
Contraindication to study medication                 0                 0                 0                 0                 0                 0                 1                 0  
Creatinine/eGFR                 0                 0                 0                 0                 0                 0                 11                 1  
Death                 0                 0                 0                 0                 0                 0                 1                 0  
Excluded medication                 0                 0                 0                 0                 0                 0                 2                 0  
Lack of Efficacy                 0                 0                 0                 0                 0                 0                 3                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 9                 1  
Non-compliance with study drug                 0                 0                 0                 0                 0                 0                 0                 1  
Physician Decision                 0                 0                 0                 0                 0                 0                 4                 1  
Protocol Violation                 0                 0                 0                 0                 0                 0                 2                 1  
Site discontinued study participation                 0                 0                 0                 0                 0                 0                 7                 2  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 30                 8  



  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.
Population includes all participants randomized during the base period. The extension period only included participants who completed the base period and consented to enter the extension period.

Reporting Groups
  Description
Omarigliptin 0.25 mg (Base) Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
Omarigliptin 1 mg (Base) Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Total Total of all reporting groups

Baseline Measures
    Omarigliptin 0.25 mg (Base)     Omarigliptin 1 mg (Base)     Omarigliptin 3 mg (Base)     Omarigliptin 10 mg (Base)     Omarigliptin 25 mg (Base)     Placebo (Base)     Total  
Number of Participants  
[units: participants]
  113     115     114     115     114     114     685  
Age  
[units: Years]
Mean (Standard Deviation)
  54.3  (8.9)     55.7  (8.5)     55.3  (8.5)     54.4  (10.0)     55.1  (8.5)     55.9  (8.4)     55.1  (8.8)  
Gender  
[units: Participants]
             
Female     48     48     49     59     45     49     298  
Male     65     67     65     56     69     65     387  
Hemoglobin A1c (A1C) [1]
[units: Percent]
Mean (Standard Deviation)
  8.1  (0.9)     8.0  (0.9)     7.9  (0.9)     8.0  (0.9)     8.1  (1.0)     8.1  (0.9)     8.1  (0.9)  
2-hour post meal glucose (2-hr PMG) [2]
[units: mg/dL]
Mean (Standard Deviation)
  229.4  (63.7)     229.3  (64.5)     234.7  (81.7)     231.6  (72.3)     245.3  (82.7)     241.4  (72.2)     235.2  (73.2)  
Fasting plasma glucose (FPG) [3]
[units: mg/dL]
Mean (Standard Deviation)
  170.3  (45.3)     169.4  (42.4)     169.0  (42.6)     166.8  (37.6)     173.9  (47.6)     171.9  (42.8)     170.2  (43.0)  
[1] Participants with data: Omariglptin 0.25 mg, n=113; Omariglptin 1 mg, n=115; Omariglptin 3 mg, n=114; Omariglptin 10 mg, n=115; Omariglptin 25 mg, n=113; Placebo, n=113; Total, n=683
[2] Participants with data: Omariglptin 0.25 mg, n=111; Omariglptin 1 mg, n=113; Omariglptin 3 mg, n=113; Omariglptin 10 mg, n=112; Omariglptin 25 mg, n=111; Placebo, n=110; Total, n=670
[3] Participants with data: Omariglptin 0.25 mg, n=113; Omariglptin 1 mg, n=115; Omariglptin 3 mg, n=114; Omariglptin 10 mg, n=115; Omariglptin 25 mg, n=114; Placebo, n=113; Total, n=684



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Plasma A1C Levels at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period   [ Time Frame: Up to 16 weeks (including 28 days following the last dose of study drug) ]

3.  Primary:   Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period   [ Time Frame: Up to 12 weeks ]

4.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period   [ Time Frame: Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period) ]

5.  Primary:   Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period   [ Time Frame: Up to 66 weeks (Weeks 12 to 78) ]

6.  Secondary:   Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

7.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12   [ Time Frame: Baseline (Week 0) and Week 12 ]

8.  Secondary:   Mean Plasma A1C Level at Baseline of the Extension Period   [ Time Frame: Baseline (Week 0) ]

9.  Secondary:   Change From Baseline in Plasma A1C Levels at Week 78   [ Time Frame: Baseline (Week 0) and Week 78 ]

10.  Secondary:   Mean 2h-PMG Level at Baseline of the Extension Period   [ Time Frame: Baseline (Week 0) ]

11.  Secondary:   Change From Baseline in 2h-PMG at Week 78   [ Time Frame: Baseline (Week 0) and Week 78 ]

12.  Secondary:   Mean FPG Level at Baseline of the Extension Period   [ Time Frame: Baseline (Week 0) ]

13.  Secondary:   Change From Baseline in FPG Levels at Week 78   [ Time Frame: Baseline (Week 0) and Week 78 ]


  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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01217073     History of Changes
Other Study ID Numbers: 3102-006
2010-022193-13 ( EudraCT Number )
2011-000656-42 ( EudraCT Number )
Study First Received: October 6, 2010
Results First Received: September 29, 2015
Last Updated: November 25, 2015
Health Authority: United States: Food and Drug Administration