| Trial ID: | L4860 |
| Source ID: | NCT00541450
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| Associated Drug: |
Comparator: Sitagliptin Phosphate (Sitagliptin)
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| Title: |
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00541450/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: Comparator: sitagliptin phosphate (sitagliptin)|DRUG: sitagliptin phosphate (+) metformin hydrochloride|DRUG: Comparator: pioglitazone|DRUG: Matching placebo to pioglitazone|DRUG: Matching placebo to sitagliptin|DRUG: Matching Placebo to Sita/Met FDC
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| Outcome Measures: |
Primary: Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks, The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin., Baseline to 40 weeks|Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks, The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin., Baseline to 12 weeks | Secondary: Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks, The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40., Baseline and 40 weeks|Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks, The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate., Baseline to 12 weeks|Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks, The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40., Baseline and 40 weeks|Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks, The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate., Baseline to 12 weeks
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| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
492
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2008-01-15
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| Completion Date: |
2010-01-16
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| Results First Posted: |
2011-04-14
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| Last Update Posted: |
2017-05-12
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT00541450
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