| Trial ID: | L6127 |
| Source ID: | NCT01076075
|
| Associated Drug: |
Sitagliptin Phosphate
|
| Title: |
A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01076075/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sitagliptin phosphate|DRUG: Comparator: placebo to pioglitazone|DRUG: Comparator: placebo to Sitagliptin|DRUG: Comparator: pioglitazone|DRUG: Glimepiride or gliclazide|DRUG: Metformin|DRUG: Pioglitazone rescue therapy
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1C (%) at Week 24, Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin., Baseline and Week 24|Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54, Week 0 to Week 54|Number of Participants Discontinuing Study Drug Due to An Adverse Event, Week 0 to Week 54 | Secondary: Change From Baseline in 2-hour Post-Meal Glucose at Week 24, Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal., Baseline and Week 24|Change From Baseline in Fasting Plasma Glucose at Week 24, Change from baseline reflects the Week 24 value minus the baseline value., Baseline to Week 24
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
427
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-06-03
|
| Completion Date: |
2012-01-19
|
| Results First Posted: |
2012-08-07
|
| Last Update Posted: |
2017-06-05
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| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT01076075
|
