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Clinical Trial Details

Trial ID: L7384
Source ID: NCT00411554
Associated Drug: Sitagliptin Phosphate
Title: A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00411554/results
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Interventions: DRUG: sitagliptin phosphate|DRUG: Comparator: voglibose
Outcome Measures: Primary: Change From Baseline in HbA1c at Week 12, HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent., Baseline and Week 12 | Secondary: Change From Baseline in Fasting Plasma Glucose at Week 12, Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0., Baseline and Week 12|Change From Baseline in 2 Hour Postprandial Glucose at Week 12, Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0., Baseline and Week 12
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 319
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-01
Completion Date: 2007-08
Results First Posted: 2009-09-25
Last Update Posted: 2016-02-05
Locations:
URL: https://clinicaltrials.gov/show/NCT00411554