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Study Results
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Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)(COMPLETED)
This study has been completed.
Study NCT00885352   Information provided by Merck

First Received on April 20, 2009.   Last Updated on December 27, 2011   History of Changes
Results First Received: November 4, 2011  
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: Comparator: Placebo
Drug: Pioglitazone
Drug: Metformin
Drug: Glipizide

  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
Lab abnormalities (the reason for discontinuation cited below) included creatinine, creatinine clearance, and estimated glomerular filtration rate.

Reporting Groups
  Description
Sitagliptin Sitagliptin 100 mg once daily
Placebo Placebo to sitagliptin once daily

Participant Flow:   Overall Study
    Sitagliptin     Placebo  
STARTED     157     156  
COMPLETED     149     136  
NOT COMPLETED     8     20  
Adverse Event                 2                 3  
Lost to Follow-up                 2                 2  
Physician Decision                 0                 3  
Protocol Violation                 0                 2  
Withdrawal by Subject                 1                 5  
Contradiction to study medication                 0                 2  
Excluded medication                 2                 2  
Lab abnormalities                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Sitagliptin Sitagliptin 100 mg once daily
Placebo Placebo to sitagliptin once daily

Baseline Measures
    Sitagliptin     Placebo     Total  
Number of Participants  
[units: participants]
  157     156     313  
Age  
[units: years]
Mean ± Standard Deviation
  55.7  ± 8.7     56.4  ± 9.4     56.1  ± 9.0  
Gender  
[units: participants]
     
Female     60     58     118  
Male     97     98     195  
Hemoglobin A1c (A1C)  
[units: Percent of gylcosylated hemoglobin]
Mean ± Standard Deviation
  8.8  ± 1.0     8.7  ± 1.0     8.7  ± 1.0  
2-hour post-meal glucose (PMG) [1]
[units: mg/dL]
Mean ± Standard Deviation
  275.5  ± 66.4     266.0  ± 62.4     270.8  ± 64.5  
Fasting plasma glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation
  179.3  ± 44.3     173.6  ± 38.9     176.5  ± 41.7  
[1] Participant population included 147 sitagliptin participants and 147 placebo participants.



  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1c (A1C) at Week 26   [ Time Frame: Baseline and Week 26 ]

2.  Secondary:   Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26   [ Time Frame: Baseline and Week 26 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26   [ Time Frame: Baseline and Week 26 ]


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00885352     History of Changes
Other Study ID Numbers: MK-0431-128, 2009_577
Study First Received: April 20, 2009
Results First Received: November 4, 2011
Last Updated: December 27, 2011
Health Authority: United States: Food and Drug Administration