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

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ClinicalTrials.gov Identifier: NCT00482729
Recruitment Status : Completed
First Posted : June 5, 2007
Results First Posted : March 15, 2010
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: sitagliptin phosphate (+) metformin hydrochloride
Drug: metformin

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 		 625   621   1246 
Age 
[Units: Years]
Mean (Standard Deviation) 		 49.4  (10.5)   50.0  (10.5)   49.7  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      272  43.5%      266  42.8%      538  43.2% 
Male      353  56.5%      355  57.2%      708  56.8% 
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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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
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

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


Publications of Results:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482729     History of Changes
Other Study ID Numbers: 0431A-079
MK0431A-079
2007_548
First Submitted: May 31, 2007
First Posted: June 5, 2007
Results First Submitted: December 9, 2009
Results First Posted: March 15, 2010
Last Update Posted: June 9, 2017