MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00532935
First received: September 19, 2007
Last updated: August 15, 2013
Last verified: August 2013
Results First Received: September 23, 2010  
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: Comparator: pioglitazone

  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: 19-Mar-2008

Last Patient Last Visit: 23-Oct-2009

Seventy-four medical clinics worldwide (19 sites in the United States, 31 in Eastern Europe, and 24 in the rest of the world).


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patients 18-78 years old with Type 2 Diabetes Mellitus (T2DM), drug-naïve (off antihyperglycemic agent

[AHA] for at least 3 months prior to screening, and a maximum 4 weeks cumulative AHA therapy over the

previous 3 years), hemoglobin A1C 7.5 to 12% were eligible. Eligible patients underwent a 2-week placebo

run-in period prior to randomization.


Reporting Groups
  Description
Sitagliptin/Metformin Fixed-Dose Combination The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC 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. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
Pioglitazone The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.

Participant Flow:   Overall Study
    Sitagliptin/Metformin Fixed-Dose Combination     Pioglitazone  
STARTED     261 [1]   256 [1]
COMPLETED     210     204  
NOT COMPLETED     51     52  
Adverse Event                 11                 12  
Lack of Efficacy                 0                 3  
Lost to Follow-up                 10                 6  
Physician Decision                 4                 5  
Pregnancy                 1                 0  
Protocol Violation                 4                 2  
Withdrawal by Subject                 10                 9  
Protocol Specific Criteria                 11                 15  
[1] Excludes 1 patient who was randomized twice at different sites.



  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
Sitagliptin/Metformin Fixed-Dose Combination The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC 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. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
Pioglitazone The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin/Metformin Fixed-Dose Combination     Pioglitazone     Total  
Number of Participants  
[units: participants]
  261     256     517  
Age  
[units: years]
Mean ± Standard Deviation
  52.4  ± 10.7     52.2  ± 11     52.3  ± 10.8  
Gender  
[units: participants]
     
Female     118     122     240  
Male     143     134     277  
Race/Ethnicity, Customized  
[units: participants]
     
White     168     167     335  
Black     6     5     11  
American Indian     2     0     2  
Asian     58     55     113  
Multi-racial     27     29     56  
Hemoglobin A1C (A1C)  
[units: Percent of glycosylated hemoglobin (A1C)]
Mean ± Standard Deviation
  9.0  ± 1.3     8.9  ± 1.3     8.9  ± 1.3  
Fasting Plasma Glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation
  190.6  ± 53.4     188.9  ± 57.1     189.8  ± 55.2  
2-Hour Post-Meal Glucose (2-HR PMG)  
[units: mg/dL]
Mean ± Standard Deviation
  273.7  ± 84.8     278.8  ± 86.4     276.2  ± 85.5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in A1C at Week 32   [ Time Frame: Baseline and Week 32 ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1   [ Time Frame: Baseline and Week 1 ]

3.  Secondary:   Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32   [ Time Frame: Baseline and Week 32 ]

4.  Secondary:   Change From Baseline in FPG at Week 32   [ Time Frame: Baseline and Week 32 ]

5.  Secondary:   Percent of Participants With A1C <7.0% at Week 32   [ Time Frame: Week 32 ]


  Serious Adverse Events


  Other Adverse Events


  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
Unknown to the Sponsor and the investigators, two patients in the study were randomized twice (each at two different sites). Data for these patients were deemed unreliable and excluded from all analyses (efficacy and safety).  


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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00532935     History of Changes
Other Study ID Numbers: 0431A-066, 2007_510
Study First Received: September 19, 2007
Results First Received: September 23, 2010
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration