Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01545388
First received: March 1, 2012
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: February 10, 2014  
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: Sitagliptin
Drug: Metformin
Drug: 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
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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
Metformin 500 mg q.d. Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
Metformin 250 mg b.i.d. Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
Placebo Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.

Participant Flow:   Overall Study
    Metformin 500 mg q.d.     Metformin 250 mg b.i.d.     Placebo  
STARTED     138     133     66  
COMPLETED     130     122     58  
NOT COMPLETED     8     11     8  
Adverse Event                 2                 4                 1  
Lack of Efficacy                 3                 2                 5  
Participant moved or relocated                 1                 0                 0  
Withdrawal by Subject                 1                 4                 2  
Not specified                 1                 1                 0  



  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.
All participants as treated population defined as all randomized participants.

Reporting Groups
  Description
Metformin 500 mg q.d. Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
Metformin 250 mg b.i.d. Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
Placebo Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
Total Total of all reporting groups

Baseline Measures
    Metformin 500 mg q.d.     Metformin 250 mg b.i.d.     Placebo     Total  
Number of Participants  
[units: participants]
  138     133     66     337  
Age  
[units: Years]
Mean ± Standard Deviation
  59.46  ± 9.61     59.65  ± 9.22     60.05  ± 9.30     59.65  ± 9.37  
Gender  
[units: Participants]
       
Female     52     46     28     126  
Male     86     87     38     211  
Hemoglobin A1c (HbA1c)  
[units: Percent¬†of¬†glycosylated¬†hemoglobin]
Mean ± Standard Deviation
  7.60  ± 0.83     7.40  ± 0.68     7.53  ± 0.77     7.51  ± 0.76  
Fasting plasma glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation
  158.58  ± 32.45     148.98  ± 26.27     154.27  ± 27.51     153.95  ± 29.42  



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

2.  Primary:   Percentage of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Up to 26 weeks ]

3.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 24 weeks ]

4.  Secondary:   Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)   [ 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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01545388     History of Changes
Other Study ID Numbers: 0431A-136, ONO-5435A
Study First Received: March 1, 2012
Results First Received: February 10, 2014
Last Updated: August 11, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency