MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00482729 |
Recruitment Status :
Completed
First Posted : June 5, 2007
Results First Posted : March 15, 2010
Last Update Posted : June 9, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Study Type | Interventional |
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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 |
Enrollment | 1246 |
Participant Flow
Recruitment Details | 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 | 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. |
Arm/Group Title | Sita/Met FDC | Metformin |
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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. | 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. |
Period Title: Overall Study | ||
Started | 626 [1] | 624 [2] |
Completed Phase A | 484 | 482 |
Completed Phase B | 409 | 406 |
Completed | 409 | 406 |
Not Completed | 217 | 218 |
Reason Not Completed | ||
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
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Baseline Characteristics
Arm/Group Title | Sita/Met FDC | Metformin | Total | |
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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. | 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 of all reporting groups | |
Overall Number of Baseline Participants | 625 | 621 | 1246 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 625 participants | 621 participants | 1246 participants | |
49.4 (10.5) | 50.0 (10.5) | 49.7 (10.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 625 participants | 621 participants | 1246 participants | |
Female |
272 43.5%
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266 42.8%
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538 43.2%
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Male |
353 56.5%
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355 57.2%
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708 56.8%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 625 participants | 621 participants | 1246 participants |
Asian | 17 | 24 | 41 | |
Black | 82 | 88 | 170 | |
White | 508 | 489 | 997 | |
Other | 18 | 20 | 38 | |
Hemoglobin A1c (A1C)
Mean (Standard Deviation) Unit of measure: Percent |
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Number Analyzed | 625 participants | 621 participants | 1246 participants | |
9.91 (1.83) | 9.83 (1.77) | 9.87 (1.80) |
Outcome Measures
Adverse Events
Limitations and Caveats
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
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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 |
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 |