MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482729
First received: May 31, 2007
Last updated: November 12, 2013
Last verified: November 2013
Results First Received: December 9, 2009  
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 phosphate (+) metformin hydrochloride
Drug: 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
First Patient In: 26-Jun-2007; Last Patient Last Visit for end of study: 28-Apr-2009; Two-hundred four medical clinics in the United States (US) and 5 in Puerto Rico.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 18-78 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c [A1C] >7.5% at screening visit) who were appropriate for treatment with oral antihyperglycemic therapy and had not been on an anti-hyperglycemic agent (AHA) in the last 4 months were eligible to participate.

Reporting Groups
  Description
Sita/Met FDC The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Metformin The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.

Participant Flow:   Overall Study
    Sita/Met FDC     Metformin  
STARTED     626 [1]   624 [2]
Completed Phase A     484     482  
Completed Phase B     409     406  
COMPLETED     409     406  
NOT COMPLETED     217     218  
Adverse Event                 29                 33  
Creatinine/Creatinine Clearance Criteria                 0                 2  
Hyperglycemia Criteria                 7                 5  
Lack of Efficacy                 4                 16  
Lost to Follow-up                 86                 66  
Physician Decision                 10                 7  
Pregnancy                 4                 2  
Protocol Violation                 10                 18  
Withdrawal by Subject                 67                 69  
[1] Site 079011301 was identified as non-compliant and 1 patient was excluded from all analysis
[2] Site 079011301 was identified as non-compliant and 3 patients were excluded from all analysis



  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
Sita/Met FDC The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Metformin The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Total Total of all reporting groups

Baseline Measures
    Sita/Met FDC     Metformin     Total  
Number of Participants  
[units: participants]
  625     621     1246  
Age  
[units: years]
Mean ± Standard Deviation
  49.4  ± 10.5     50.0  ± 10.5     49.7  ± 10.5  
Gender  
[units: participants]
     
Female     272     266     538  
Male     353     355     708  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     17     24     41  
Black     82     88     170  
White     508     489     997  
Other     18     20     38  
Hemoglobin A1c (A1C)  
[units: Percent]
Mean ± Standard Deviation
  9.91  ± 1.83     9.83  ± 1.77     9.87  ± 1.80  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1c (A1C) at Week 18   [ Time Frame: Baseline and Week 18 ]

2.  Secondary:   Number of Patients With A1C < 7.0% at Week 18   [ Time Frame: Week 18 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18   [ Time Frame: Baseline and Week 18 ]

4.  Other Pre-specified:   Change From Baseline in A1C at Week 44   [ Time Frame: Baseline and Week 44 ]

5.  Other Pre-specified:   Number of Patients With A1C < 7.0% at Week 44   [ Time Frame: Week 44 ]


  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
Site 079011301 was non-compliant with Good Clinical Practice (GCP). Data from the 4 patients at this site are included in the Participant Flow summary, but are excluded from all other summaries and analyses.


  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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482729     History of Changes
Other Study ID Numbers: 0431A-079, MK0431A-079, 2007_548
Study First Received: May 31, 2007
Results First Received: December 9, 2009
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration